MedPath

Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

Phase 2
Completed
Conditions
Ulcerative Colitis
Interventions
Registration Number
NCT02958865
Lead Sponsor
Pfizer
Brief Summary

The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
319
Inclusion Criteria
  • Diagnosis of ulcerative colitis for greater than/equal to 3 months.
  • Moderate to severe active ulcerative colitis
  • Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
Exclusion Criteria
  • Pregnant or breastfeeding
  • Clinical findings suggestive of Crohn's Disease
  • History of bowel surgery within 6 months

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PF-06700841 Drug Dose Level 3PF-06700841 or PlaceboDelivered orally for 8 weeks.
PF-06651600 Drug Dose Level 1PF-06651600 or PlaceboDelivered orally for 8 weeks
PF-06651600 Drug Dose Level 2PF-06651600 or PlaceboDelivered orally for 8 weeks
PF-06700841 PlaceboPF-06700841 or PlaceboDelivered orally for 8 weeks.
PF-06651600 Drug Dose Level 4PF-06651600Delivered orally for 24 weeks.
PF-06651600 Drug Dose Level 3PF-06651600 or PlaceboDelivered orally for 8 weeks.
PF-06651600 PlaceboPF-06651600 or PlaceboDelivered orally for 8 weeks.
PF-06700841 Drug Dose Level 4PF-06700841Delivered orally for 24 weeks.
PF-06700841 Drug Dose Level 1PF-06700841 or PlaceboDelivered orally for 8 weeks
PF-06700841 Drug Dose Level 2PF-06700841 or PlaceboDelivered orally for 8 weeks.
Primary Outcome Measures
NameTimeMethod
Total Mayo Score at Week 8 (Induction Period)Week 8

The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score.

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)Week 8 to Week 32

The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)From Day 1 up to Week 8

An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.

Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period)Week 8

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Symptomatic remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscores of 0.

Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period)Week 8

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Deep remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a zero on both endoscopic and rectal bleeding subscore.

Change From Baseline in Total Mayo Score at Week 8 (Induction Period)Baseline, Week 8

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.

Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period)Baseline, Weeks 4 and 8

IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. Baseline value is defined as the last non-missing measurement collected prior to or on Day 1.

Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)From Week 8 up to Week 32

An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.

Number of Participants With Abnormal ECG Findings (Chronic Period)Week 8 to Week 32

The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below.

Number of Participants With Serious Infections (Chronic Period)Week 8 to Week 32

Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.

Number of Participants With Laboratory Test Abnormalities (Induction Period)From Day 1 up to Week 8

The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.

Number of Participants With Abnormal Vital Signs Data (Induction Period)From screening to Week 8

The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.

Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period)Week 8

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response was defined as decrease from baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.

Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period)Week 8

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Endoscopic remission was defined as endoscopic subscore of 0.

Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)Baseline, Weeks 2, 4 and 8

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. The partial Mayo score does not incorporate the endoscopy score and the partial Mayo score ranges from 0 to 9.

Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)Week 4 and Week 8

IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease specific quality of life in participants with inflammatory bowel disease (IBD). The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.

Number of Participants With Laboratory Test Abnormalities (Chronic Period)From Week 8 to Week 32

The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance.

Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period)Week 32

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.

Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period)Week 32

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic appearance was defined at Mayo endoscopic subscore of ≤1.

Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)From Week 8 to Week 32

The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.

Number of Participants With Abnormal Vital Signs Data (Chronic Period)From Week 8 to Week 32

The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.

Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)From Day 1 up to Week 8

The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.

Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)From Day 1 up to Week 8

The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.

Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)Week 8 to Week 32

The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL).

Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)From Day 1 up to Week 8

The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL)

Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)From screening to Week 8

The number of participants with abnormal ECG findings during the induction period (from Day 1 to Week 8) are reported below. The criteria of test abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.

Number of Participants With Serious Infections (Induction Period)From Day 1 up to Week 8

Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials including Listeria encephalitis, Pneumonia, Viral infection.

Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period)Week 8

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.

Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period)Week 8

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic subscore appearance was defined at Mayo endoscopic subscore of ≤1.

Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)Week 4 and Week 8

IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.

Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period)Baseline, Week 4 and 8

IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.

Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period)Week 4 and Week 8

IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. The improvement in IBDQ bowel symptom domain was defined as an increase of ≥1.2 points from baseline in average score among bowel symptoms domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).

Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period)Week 4 and Week 8

For EQ-5D 3L, participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state. The EQ-5D VAS records the respondent's self rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).

Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period)Week 4 and Week 8

The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). These 8 domains can also be summarized as physical and mental component scores. The summary component scores, Physical Component Summary (PCS) and Mental Component Summary (MCS), are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH . All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The minimum and maximum scores of the PCS Score are 6.1 and 79.7, respectively. The minimum and maximum scores of the MCS Score are -3.8 and 78.7, respectively.

Total Mayo Score at Week 32 (Chronic Period)Week 32

The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.

Trial Locations

Locations (183)

Dothan Surgery Center

🇺🇸

Dothan, Alabama, United States

Gut P.C., dba Digestive Health Specialists of the Southeast

🇺🇸

Dothan, Alabama, United States

Southern California Research Institute Medical Group/West Gastroenterology Medical Group/Airport En-

🇺🇸

Los Angeles, California, United States

West Coast Endoscopy Center

🇺🇸

Clearwater, Florida, United States

University of Miami Hospital and Clinics

🇺🇸

Miami, Florida, United States

University of Miami Hospital

🇺🇸

Miami, Florida, United States

Southwest Gastroenterology

🇺🇸

Oak Lawn, Illinois, United States

Cascades Endoscopy Center

🇺🇸

Columbia, Maryland, United States

Parkland Health and Hospital System

🇺🇸

Dallas, Texas, United States

UT Southwestern Medical Center - CRU Aston

🇺🇸

Dallas, Texas, United States

UT Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

Baylor College of Medicine- Baylor Medical Center

🇺🇸

Houston, Texas, United States

Baylor St. Luke's Medical Center Endoscopy-McNair Campus

🇺🇸

Houston, Texas, United States

Gulf Coast Research Group

🇺🇸

Houston, Texas, United States

Verity Research

🇺🇸

Fairfax, Virginia, United States

University of Washington

🇺🇸

Seattle, Washington, United States

Gastro Center of Maryland

🇺🇸

Columbia, Maryland, United States

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov

🇺🇦

Vinnytsia, Ukraine

Medical Center "Universal clinic Oberig" of "Kapital" LLC, Gastro center

🇺🇦

Kyiv, Ukraine

Municipal Non-Profit Enterprise "Lviv Clinical Emergency Care Hospital"

🇺🇦

Lviv, Ukraine

Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", gastroenterology department,

🇺🇦

Chernivtsi, Ukraine

KO-MED Centra Kliniczne Pulawy

🇵🇱

Pulawy, Poland

KM Management spol. s.r.o.

🇸🇰

Nitra, Slovakia

Regional Consultative Polyclinic

🇺🇦

Chernivtsi, Ukraine

Bristol Hospital

🇺🇸

Bristol, Connecticut, United States

Long Beach Clinical Trials Services Inc.

🇺🇸

Long Beach, California, United States

Diabetes and Endocrinology Unit

🇮🇱

Tel Aviv, Israel

AOU Sant'Orsola-Malpighi

🇮🇹

Bologna, BO, Italy

Shaare Zedek Medical Center

🇮🇱

Jerusalem, Israel

Istituto Clinico Humanitas

🇮🇹

Rozzano, Milan (MI), Italy

Javorszky Odon Korhaz, Gasztroenterologia

🇭🇺

Vac, Hungary

Fakultni nemocnice v Motole

🇨🇿

Praha 5, Czechia

ETG Kielce

🇵🇱

Kielce, Poland

ENDOSKOPIA Sp. z o. o.

🇵🇱

Sopot, Poland

H-T. Centrum Medyczne

🇵🇱

Tychy, Poland

IRCCS Saverio De Bellis

🇮🇹

Castellana Grotte, Bari, Italy

Severance Hospital, Yonsei University Health System

🇰🇷

Seoul, Korea, Republic of

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I. Belgyogyaszati Gasztroenterologiai Osztaly

🇭🇺

Budapest, Hungary

MHAT Dobrich AD

🇧🇬

Dobrich, Bulgaria

SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego w Bialymstoku

🇵🇱

Bialystok, Poland

Centrum Zdrowia MDM

🇵🇱

Warszawa, Poland

WIP Warsaw IBD Point Profesor Kierkus

🇵🇱

Warszawa, Poland

A.O.U. Policlinico G. Martino

🇮🇹

Messina, ME, Italy

Semmelweis Egyetem, II. Belgyogyaszati Klinika

🇭🇺

Budapest, Hungary

Pannonia Maganorvosi Centrum

🇭🇺

Budapest, Hungary

"MHAT-Blagoevgrad" AD

🇧🇬

Blagoevgrad, Bulgaria

Kyungpook National University Hospital

🇰🇷

Daegu, Korea, Republic of

Clalit Health Services

🇮🇱

Bat-Yam, Israel

Clinical Hospital Centre Bezanijska Kosa Clinic for Internal Medicine

🇷🇸

Belgrade, Serbia

General Hospital "Djordje Joanovic"

🇷🇸

Zrenjanin, Serbia

MUDr. Frantisek Horvath Gastroenterologia

🇸🇰

Sahy, Slovakia

Private Enterprise of Private Manufacturing Company "Acinus", Medical and Diagnostic Center

🇺🇦

Kropyvnytskyi, Ukraine

Azienda Ospedaliero Universitaria Pisana

🇮🇹

Pisa, PI, Italy

Ankara Universitesi Tip Fakultesi, Ibn-i Sina Hastanesi, Ic Hastaliklari Anabilim Dali,

🇹🇷

Ankara, Turkey

Hacettepe Universitesi Tip Fakultesi

🇹🇷

Ankara, Turkey

Hospital Universitari de Bellvitge

🇪🇸

L'Hospitalet de Llobregat, Barcelona, Spain

The Catholic University of Korea, Seoul St. Mary's Hospital

🇰🇷

Seoul, Korea, Republic of

Hospital Universitario Fundacion Alcorcon

🇪🇸

Alcorcon, Madrid, Spain

Federal State Budgetary Scientific Institution

🇷🇺

Novosibirsk, Russian Federation

Lexmedica

🇵🇱

Wroclaw, Poland

ENDOMED, s.r.o.

🇸🇰

Vranov nad Toplou, Slovakia

Municipal Institution "Kherson City Clinical Hospital n.a. Afanasiy and Olga Tropiny"

🇺🇦

Kherson, Ukraine

Municipal Institution "Odesa Regional Clinical Hospital"

🇺🇦

Odesa, Ukraine

Ankara Universitesi Tip Fakultesi, Ibn-i-Sina Hastanesi

🇹🇷

Ankara, Turkey

Medical University REAVIZ

🇷🇺

Samara, Russian Federation

State Budgetary Institution of Healthcare Yaroslavl Regional Clinical Hospital

🇷🇺

Yaroslavl, Russian Federation

Ai Centrum Medyczne Sp. Z O.O. Sp.K.

🇵🇱

Poznan, Poland

Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology

🇷🇸

Nis, Serbia

General Hospital Subotica

🇷🇸

Subotica, Serbia

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

🇹🇷

Ankara, Turkey

Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

🇹🇷

Istanbul, Turkey

FGBOU VO OmGMU Minzdrava Rossii

🇷🇺

Omsk, Russian Federation

State Budgetary Institution of Ryazan Region "Regional Clinical Hospital"

🇷🇺

Ryazan, Russian Federation

Hospital Universitario Puerta de Hierro de Majadahonda

🇪🇸

Majadahonda, Madrid, Spain

Istanbul Universitesi Istanbul Tıp Fakultesi

🇹🇷

Istanbul, Turkey

Mersin Universitesi Tip Fakultesi Hastanesi

🇹🇷

Mersin, Turkey

MNCECCH No.2 n.a. PROF O.O. SHALIMOV of KHARKIV CITY COUNCIL

🇺🇦

Kharkiv, Ukraine

Lviv clinical hospital on Railway Transport of Health Care Center branch of PJSC Ukrainian Railway

🇺🇦

Lviv, Ukraine

FSBEI HE "Rostov State Medical University" of the Ministry of Healthcare of the Russian Federation

🇷🇺

Rostov-on-Don, Russian Federation

Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"

🇷🇺

Samara, Russian Federation

Clinical Centre of Kragujevac

🇷🇸

Kragujevac, Serbia

Abawi spol. s r.o

🇸🇰

Bratislava, Slovakia

Istanbul Universitesi Cerrahpasa Tip Fakultesi

🇹🇷

Istanbul, Turkey

FSAEI HE I.M.Sechenov 1st Moscow State Medical University of the MoH of the RF (Sechenov University)

🇷🇺

Moscow, Russian Federation

Hospital Universitario Marques de Valdecilla

🇪🇸

Santander, Cantabria, Spain

Kyiv Municipal Clinical Hospital #18, Proctology Department

🇺🇦

Kyiv, Ukraine

Municipal Institution of Ternopil regional council Ternopil University Hospital

🇺🇦

Ternopil, Ukraine

Municipal Institution "Uzhgorod Regional Hospital"

🇺🇦

Uzhgorod, Ukraine

Zakarpattia Regional Clinical Hospital n.a. A. Novak,

🇺🇦

Uzhgorod, Ukraine

Nordsjaellands Hospital Frederikssund

🇩🇰

Frederikssund, Denmark

ASST Rhodense - Ospedale di Circolo di Rho

🇮🇹

Rho, Milano (MI), Italy

Policlinico Universitario Campus Biomedico

🇮🇹

Roma, RM, Italy

AOU Policlinico di Modena

🇮🇹

Modena, Italy

Erciyes Universitesi Tip Fakultesi

🇹🇷

Kayseri, Turkey

Kocaeli Universitesi Tip Fakultesi

🇹🇷

Kocaeli, Turkey

RIAT Limited Liability Company (RIAT LLC)

🇷🇺

Saint-Petersburg, Russian Federation

Saint-Petersburg State Budgetary Healthcare Institution

🇷🇺

Saint-Petersburg, Russian Federation

LLC Medical Company Hepatolog

🇷🇺

Samara, Russian Federation

Hospital Universitari i Politecnic La Fe

🇪🇸

Valencia, Spain

Hospital Clinic de Barcelona

🇪🇸

Barcelona, Spain

Migdal Hamea Clinic

🇮🇱

Tel Aviv, Israel

Tolna Megyei Balassa Janos Korhaz

🇭🇺

Szekszard, Hungary

Clinical Application Laboratories, INC.

🇺🇸

San Diego, California, United States

Medical Associates Research Group

🇺🇸

San Diego, California, United States

Digestive Disease Specialists, Inc.

🇺🇸

Oklahoma City, Oklahoma, United States

Sagact, Pllc.

🇺🇸

San Antonio, Texas, United States

Sagact, Pllc

🇺🇸

San Antonio, Texas, United States

San Diego Endoscopy Center

🇺🇸

San Diego, California, United States

Front Range Endoscopy Center

🇺🇸

Colorado Springs, Colorado, United States

Connecticut Clinical Research Institute

🇺🇸

Bristol, Connecticut, United States

Central Connecticut Endoscopy Center

🇺🇸

Plainville, Connecticut, United States

Chevy Chase Endoscopy Center

🇺🇸

Chevy Chase, Maryland, United States

MGG Group Co. Inc., Chevy Chase Clinical Research

🇺🇸

Chevy Chase, Maryland, United States

Feldman ENT

🇺🇸

Chevy Chase, Maryland, United States

Brigham and Women's Hospital

🇺🇸

Chestnut Hill, Massachusetts, United States

Concorde medical Group, PLLC

🇺🇸

New York, New York, United States

Kips Bay Endoscopy Center

🇺🇸

New York, New York, United States

NYU Langone Medical Center

🇺🇸

New York, New York, United States

New York University Langone Medical Center

🇺🇸

New York, New York, United States

NYU Clinical Cancer Center

🇺🇸

New York, New York, United States

Weill Cornell Medical College - New York Presbyterian Hospital

🇺🇸

New York, New York, United States

NYU Medical Science Building

🇺🇸

New York, New York, United States

New York Presbyterian Hospital-Weill Cornell Medical College

🇺🇸

New York, New York, United States

University of Rochester Medical Center

🇺🇸

Rochester, New York, United States

Weill Cornell Medical College-New York Presbyterian Hospital

🇺🇸

New York, New York, United States

Gastro One

🇺🇸

Germantown, Tennessee, United States

Lonestar Endoscopy, LLP

🇺🇸

Southlake, Texas, United States

Texas Digestive Disease Consultants

🇺🇸

Southlake, Texas, United States

Blue Ridge Medical Research

🇺🇸

Lynchburg, Virginia, United States

McGuire DVAMC

🇺🇸

Richmond, Virginia, United States

"Medical Center-1- Sevlievo" EOOD

🇧🇬

Sevlievo, Gabrovo, Bulgaria

AKH Wien Universitaetsklinik fuer Innere Medizin III

🇦🇹

Wien, Austria

MHAT Prof. Dr. Paraskev Stoyanov AD

🇧🇬

Lovech, Bulgaria

MC Hipocrat-2000 OOD

🇧🇬

Haskovo, Bulgaria

"MC Asklepion - researches in human medicine"" EOOD

🇧🇬

Sofia, Bulgaria

"Acibadem City Clinic UMHAT" EOOD

🇧🇬

Sofia, Bulgaria

MVZ Dachau

🇩🇪

Dachau, Germany

Nemocnice Slany, p.o.

🇨🇿

Slany, Czechia

Hepato-Gastroenterologie HK, s.r.o.

🇨🇿

Hradec Kralove, Czechia

Nemocnice Strakonice, a.s., interni oddeleni

🇨🇿

Strakonice, Czechia

Nordsjaellands Hospital Hilleroed

🇩🇰

Hilleroed, Denmark

Research institute of Clinical Medicine

🇬🇪

Tbilisi, Georgia

Amager og Hvidovre Hospital

🇩🇰

Hvidovre, Denmark

Odense Universitetshospital

🇩🇰

Odense, Denmark

Gastrostudien GbR

🇩🇪

Berlin, Germany

Krankenhaus Waldfriede e.V.

🇩🇪

Berlin, Germany

The First University Clinic of TSMU

🇬🇪

Tbilisi, Georgia

Paian MED Research GmbH

🇩🇪

Berlin, Germany

MVZ Dachau - Patientenzentrum

🇩🇪

Dachau, Germany

Eugastro GmbH

🇩🇪

Leipzig, Germany

Asklepios Westklinikum Hamburg

🇩🇪

Hamburg, Germany

Bekes Megyei Kozponti Korhaz, Rethy Pal Tagkorhaz

🇭🇺

Bekescsaba, Hungary

Azienda Ospedaliera di Padova

🇮🇹

Padova, Italy

Azienda Sanitaria Universitaria Integrata Udine

🇮🇹

Udine, Italy

Gastromed Sp. z o.o.

🇵🇱

Lublin, Poland

Keimyung University Dongsan Hospital

🇰🇷

Daegu, Korea, Republic of

EMC Instytut Medyczny S.A., Szpital Specjalistyczny EuroMediCare z Przychodnia

🇵🇱

Wroclaw, Poland

LLC "Olla-Med"

🇷🇺

Moscow, Russian Federation

S.C. Cabinet Particular Policlinic Algomed SRL

🇷🇴

Timisoara, Timis, Romania

Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila" Bucuresti

🇷🇴

Bucuresti, Sector 1,, Romania

Limited Liability Company "Medicinsky Center SibNovoMed"

🇷🇺

Novosibirsk, Russian Federation

LLC Novosibirskiy Gastrocentr

🇷🇺

Novosibirsk, Russian Federation

Novosibirskiy Gastrocenter

🇷🇺

Novosibirsk, Russian Federation

Clinical Hospital Centre Zvezdara Clinic for Internal Diseases

🇷🇸

Belgrade, Serbia

Clinical Hospital Center Zemun

🇷🇸

Zemun, Belgrade, Serbia

Hospital Universitario Virgen del Rocio

🇪🇸

Sevilla, Spain

Bulent Ecevit Universitesi Tip Fakultesi

🇹🇷

Zonguldak, Turkey

Medical Center Vitadar Consult OOD

🇧🇬

Ruse, Bulgaria

SHATPPD dr. Dimitar Gramatikov - Ruse EOOD

🇧🇬

Ruse, Bulgaria

UT Southwestern Medical Center-Clements University Hospital

🇺🇸

Dallas, Texas, United States

Universitaetsklinikum Schleswig-Holstein

🇩🇪

Kiel, Germany

Peak Gastroenterology Associates

🇺🇸

Colorado Springs, Colorado, United States

Centrum Diagnostyczno-Lecznicze Barska Sp. z o. o.

🇵🇱

Wloclawek, Poland

Melita Medical Sp z o.o.

🇵🇱

Wroclaw, Poland

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy

🇵🇱

Wroclaw, Poland

Spitalul Clinic Colentina, Sectia de Gastroenterologie

🇷🇴

Bucuresti, Romania

Weill Cornell Medical College

🇺🇸

New York, New York, United States

Orlando Gastroenterology, PA

🇺🇸

Orlando, Florida, United States

HMD Research LLC

🇺🇸

Orlando, Florida, United States

UNC Hospitals Endoscopy Center at Meadowmont

🇺🇸

Chapel Hill, North Carolina, United States

University of North Carolina at Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

Millenia Surgery Center

🇺🇸

Orlando, Florida, United States

UNC Hospitals

🇺🇸

Chapel Hill, North Carolina, United States

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