Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

Phase 3

Completed

• Conditions: Functional Constipation; Irritable Bowel Syndrome With Constipation
• Interventions: Drug: Placebo; Drug: Linaclotide

• Registration Number: NCT04026113
• Lead Sponsor: AbbVie

Brief Summary

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for child/adolescent FC. The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent IBS and modified Rome III criteria for child/adolescent FC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2019-10-01
• Primary Completion: 2024-05-20
• Study Completion: 2024-05-29
• Status Verified: 2024-10
• Results First Submitted: 2024-10-31
• Results First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Results First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

• Male and female participants must be ages 6 to 17 years (FC participants) or ages 7 to 17 years (IBS-C participants) (inclusive) at the time the participant provides assent for the study and parent/guardian/legally authorized representative (LAR) has provided signed consent;
• Participant weighs ≥18 kg at the time the participant provides assent and the parent/guardian/LAR has provided signed consent;
• Participants who meet the modified Rome III criteria for Child/Adolescent FC. For at least 2 months before the Screening Visit, the participant has had 2 or fewer defecations (with each defecation occurring in the absence of any laxative, suppository, or enema use during the preceding 24 hours) in the toilet per week.

In addition, participant meets one or more of the following criteria at least once per week for at least 2 months before the screening visit:

a. History of retentive posturing or excessive volitional stool retention; b. History of painful or hard BMs; c. History of large diameter stools that may obstruct the toilet; d. Presence of a large fecal mass in the rectum; e. At least 1 episode of fecal incontinence per week

• For IBS-C participants only: Participant meets Rome III criteria for child/adolescent IBS: At least once per week for at least 2 months before the Screening Visit, the participant experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:

  1. Improvement with defecation;
  2. Onset associated with a change in frequency of stool;
  3. Onset associated with a change in form (appearance) of stool;

• For IBS-C participants only: Participant has an average daytime abdominal pain score of ≥ 1 (at least "a tiny bit") during the 14 days before Visit 3;

• Participant is willing to discontinue any laxatives used before the Preintervention Visit in favor of the protocol- permitted rescue medicine;

• Participant has an average of fewer than 3 SBMs per week during the 14 days before the randomization day and up to the randomization (including the morning eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day). An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM;

• Participant or parent/guardian/LAR or caregiver is compliant with eDiary requirements by completing both the morning and evening assessments for 10 out of the 14 days immediately preceding the Randomization Visit;

• Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Randomization Visit prior to dosing;

• Female participants who have had their first menstrual period and are sexually active must agree to use a reliable form of contraception;

• Participant must provide written or verbal informed assent and the parent/guardian/LAR and caregiver must provide written informed consent before the initiation of any study-specific procedures;

• Participant is able to read and/or understand the assessments in the eDiary device. If the participant is 6 to 11 years of age (FC participants) or 7 to 11 years of age (IBS-C participants) and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must undergo training;

• Participant must have acquired toilet training skills.

Exclusion Criteria

• For FC participants only: Participant meets Rome III criteria for Child/Adolescent IBS: At least once per week for at least 2 months before the Screening Visit, the participant has experienced abdominal discomfort (an uncomfortable sensation not described as pain) or pain associated with 2 or more of the following at least 25% of the time:

  1. Improvement with defecation
  2. Onset associated with a change in frequency of stool
  3. Onset associated with a change in form (appearance) of stool;

• Participant reports having more than 1 loose, mushy stool (eDiary-recorded stool consistency of 6 on the Pediatric Bristol Stool Form Scale [p-BSFS]) or any watery stool (eDiary-recorded stool consistency of 7 on the p-BSFS) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during the 14 days before the randomization day and up to the randomization (including the morning eDiary assessments reported before administration of first dose of double-blind study intervention on the randomization day);

• Participant has a history of non-retentive fecal incontinence;

• Participant has (a) fecal impaction at Visit 2 after failing outpatient clean-out during the Screening Period or (b) fecal impaction at Visit 3;

• Participant has required manual disimpaction any time prior to randomization;

• Participant currently has both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia, or any unexplained anemia, or weight loss) and systemic signs of infection or colitis, or any neoplastic process;

• Participant has clinically significant findings on a physical examination, vital sign assessment, electrocardiogram (ECG), or clinical laboratory test as determined by the investigator based on consideration of whether the finding could represent a safety concern or a condition that would be exclusionary, could prevent the participant from performing any protocol assessments, or could confound study assessments;

• Participant has a history of drug or alcohol abuse;

• Participant has any of the following conditions:

  1. Celiac disease, or positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy;
  2. Cystic fibrosis;
  3. Hypothyroidism that is untreated or treated with thyroid hormone at a dose that has not been stable for at least 3 months prior to the Screening Visit;
  4. Down's syndrome or any other chromosomal disorder;
  5. Active anal fissure (Note: History of anal fissure is not an exclusion);
  6. Anatomic malformations (eg, imperforate anus, anal stenosis, anterior displaced anus);
  7. Intestinal nerve or muscle disorders (eg, Hirschprung disease, visceral myopathies, visceral neuropathies);
  8. Neuropathic conditions (eg, spinal cord abnormalities, neurofibromatosis, tethered cord, spinal cord trauma);
  9. Lead toxicity, hypercalcemia;
  10. Neurodevelopmental disabilities (early-onset, chronic disorders that share the essential feature of a predominant disturbance in the acquisition of cognitive, motor, language, or social skills, which has a significant and continuing impact on the developmental progress of an individual) producing a cognitive delay that precludes comprehension and completion of the daily eDiary (Electronic handheld device) or other study-related questionnaires (Note: Participants are excluded if the person who will be completing the daily eDiary or other study-related questionnaires meets this criterion);
  11. Inflammatory bowel disease;
  12. Childhood functional abdominal pain syndrome;
  13. Childhood functional abdominal pain;
  14. Poorly treated or poorly controlled psychiatric disorders that might influence his or her ability to participate in the study;
  15. Lactose intolerance that is associated with abdominal pain or discomfort and could confound the assessments in this study;
  16. History of cancer other than treated basal cell carcinoma of the skin; (Note: Participants with a history of cancer are allowed provided that the malignancy has been in a complete remission for at least 5 years before the Randomization Visit. A complete remission is defined as the disappearance of all signs of cancer in response to treatment);
  17. History of diabetic neuropathy.

• Participant has an acute or chronic condition that, in the investigator's opinion, would limit the participants' ability to complete or participate in this clinical study;

• Participant has a known or suspected mechanical bowel obstruction or pseudoobstruction;

• Participant has a known allergy or sensitivity to the study intervention or its components or other medications in the same drug class.

• Participant has had surgery that meets any of the following criteria:

  1. Bariatric surgery for treatment of obesity, or surgery to remove a segment of the GI tract at any time before the Screening Visit;
  2. Surgery of the abdomen, pelvis, or retroperitoneal structures during the 6 months before the Screening Visit;
  3. An appendectomy or cholecystectomy during the 60 days before the Screening Visit;
  4. Other major surgery during the 30 days before the Screening Visit;

• Participant used a protocol-specified prohibited medicine before the start of the Preintervention Period or failed to meet the stable-dose requirements of certain medications;

• Participant used rescue medication on the calendar day before the Randomization Visit and on the day of the Randomization Visit until randomized;

• Participant received a study intervention during the 30 days before the Screening Visit or is planning to receive a study intervention (other than that administered during this study);

• Participant has been randomized into any clinical study in which linaclotide was a study intervention.

• The participant has a condition or is in a situation; which, in the investigator's opinion, may put the participant at significant risk, may confound the study results ,or may interfere significantly with the participant's participation in the study;

• Participants who have positive urine drug screen results for cocaine, barbiturates, opiates, or cannabinoids will be excluded from study participation;

• Female participants who are currently pregnant or nursing, or plan to become pregnant or nurse during the clinical study;

• Participant's parent/guardian/LAR or caregiver has been directly or indirectly involved in the conduct and administration of this study as an investigator, study coordinator, or other study staff member. In addition, any participant, parent/guardian/LAR or caregiver who has a first-degree family member, significant other, or relative residing with him/her directly or indirectly who is involved in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FC Participants: Placebo	Placebo	Placebo single dose, once daily at approximately the same time each day, 30 minutes before any meal.
FC Participants: Linaclotide 72 μg	Linaclotide	Linaclotide 72 μg single dose, once daily at approximately the same time each day, 30 minutes before any meal.
IBS-C Participants: Linaclotide 145 μg	Linaclotide	Linaclotide 145 μg single dose, once daily at approximately the same time each day, 30 minutes before any meal.
IBS-C Participants: Linaclotide 290 μg	Linaclotide	Linaclotide 290 μg single dose, once daily at approximately the same time each day, 30 minutes before any meal

Primary Outcome Measures

Name	Time	Method
Functional Constipation (FC) Participants: Change From Baseline in 12-week SBM (Spontaneous Bowel Movement) Frequency Rate (SBMs/Week) During the Study Intervention Period	Baseline, up to 12 weeks	An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the bowel movement (BM) or the calendar day before the BM. Assessments of BM characteristics that determine occurrences of SBM (ie, BM frequency and rescue medication use) were measured by using the eDiary completed twice daily (morning and evening) on the eDiary (Electronic Diary) device.
Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks APS (Abdominal Pain and SBM) + 2 Responder Rate	12 Weeks	6/12 weeks APS + 2 responder=participant who meets the weekly APS + 2 responder criteria ≥6 of the 12 weeks of the intervention period. Weekly APS +2 responder=participant who has an increase of ≥2 in the SBM weekly rate from baseline, AND a decrease of ≥30% in mean abdominal pain score from baseline, during that study intervention week. Assessments of abdominal pain and BM characteristics that determine occurrences of SBMs were measured by using an eDiary completed twice daily (AM and PM). Assessments of abdominal pain were measured using a 5-point scale where 0=none and 4=a lot. A participant's abdominal pain score=mean of the non-missing abdominal pain scores during the specified period. Responder rate=percentage of participants who were 6/12 weeks APS + 2 responders. A participant had to have ≥4 completed diary days in the analysis week to be considered a responder for that week and was otherwise considered a non-responder for that week.

Secondary Outcome Measures

Name	Time	Method
Functional Constipation (FC) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period	Baseline, up to 12 weeks	Stool consistency was measured twice daily, once in the morning and once in the evening eDiary, using the 7-point ordinal pediatric Bristol Stool Form Scale (p-BSFS): Type 1: Looks like small hard lumps or balls, like pebbles; Type 2: Looks like fat sausage shape but lumpy and hard; Type 3: Looks like a sausage but with cracks on it; Type 4: Looks like a sausage or snake, smooth and soft; Type 5: Looks like chicken nuggets, soft smooth blobs; Type 6: Looks like oatmeal, fluffy mushy pieces; Type 7: Looks like a milkshake, watery. A participant's p-BSFS score for the study intervention period was the average of the non-missing p-BSFS scores from the SBMs reported by the participant during the 12-week study intervention period.
Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week SBM Frequency Rate (SBMs/Week) During the Study Intervention Period	Baseline, up to 12 Weeks	An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. Assessments of BM characteristics that determine occurrences of SBM (ie, BM frequency and rescue medication use) were measured by using the eDiary completed twice daily (morning and evening) on the eDiary (Electronic Diary) device. A participant's SBMs/week for the study intervention period was the average of the non-missing SBMs/week reported by the participant during the 12-week study intervention period.
Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Abdominal Pain During the Study Intervention Period	Baseline, up to 12 weeks	Assessments of abdominal pain were measured twice daily, once in the morning and once in the evening eDiary, using a 5-point scale where a score of 0 indicates no abdominal pain scores and a score of 4 indicates a lot of abdominal pain. Assessments of abdominal pain were measured using a 5-point scale where '0' indicates no abdominal pain and '4' indicates a lot of abdominal pain. The participant's abdominal pain score was derived as the mean of the non-missing morning and evening abdominal pain scores during the specified period.
Irritable Bowel Syndrome With Constipation (IBS-C) Participants: Change From Baseline in 12-week Stool Consistency During the Study Intervention Period	Baseline, up to 12 weeks	Stool consistency was measured twice daily, once in the morning and once in the evening eDiary, using the 7-point ordinal p-BSFS (pediatric Bristol Stool Form Scale: Type 1: Looks like small hard lumps or balls, like pebbles Type 2: Looks like fat sausage shape but lumpy and hard Type 3: Looks like a sausage but with cracks on it Type 4: Looks like a sausage or snake, smooth and soft Type 5: Looks like chicken nuggets, soft smooth blobs Type 6: Looks like oatmeal, fluffy mushy pieces Type 7: Looks like a milkshake, watery. A participant's p-BSFS score for the study intervention period was the average of the non-missing p-BSFS scores from the SBMs reported by the participant during the 12-week study intervention period.
Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks SBM + 2 Responder Rate	12 weeks	A 6/12 weeks SBM + 2 responder is a participant that meets the weekly SBM + 2 responder criteria for at least 6 out of the 12 weeks of the intervention period. A weekly SBM +2 responder is a participant who has an increase of at least 2 in the SBM weekly rate from baseline, Assessments of BM characteristics that determine occurrences of SBMs (ie, BM frequency and rescue medication use) were measured by using an eDiary completed twice daily (morning and evening). Responder rate is presented as the percentage of participants who were 6/12 weeks SBM + 2 responders.
Irritable Bowel Syndrome With Constipation (IBS-C) Participants: 6/12 Weeks Abdominal Pain Responder	12 Weeks	A 6/12 weeks abdominal pain responder is a participant that meets the weekly abdominal pain responder criteria for at least 6 out of the 12 weeks of the intervention period. A weekly abdominal pain responder is a participant who has a decrease of at least 30% in the mean abdominal pain score from baseline, during that study intervention week. Assessments of abdominal pain were measured by using an eDiary completed twice daily (morning and evening) and were measured using a 5-point scale where '0' indicates no abdominal pain and '4' indicates a lot of abdominal pain. The participant's abdominal pain score was derived as the mean of the non-missing abdominal pain scores during the specified period. Responder rate is presented as the percentage of participants who were 6/12 weeks abdominal pain responders.

Trial Locations

Locations (115)

Medclinical Research Partners LLC/ Foundation Pediatrics /ID# 232783; 🇺🇸 East Orange, New Jersey, United States

University of New Mexico /ID# 233011; 🇺🇸 Albuquerque, New Mexico, United States

The Children's Hospital at Montefiore /ID# 232638; 🇺🇸 Bronx, New York, United States

Advantage Clinical Trials /ID# 233117; 🇺🇸 Bronx, New York, United States

Columbia Univ Medical Center /ID# 233094; 🇺🇸 New York, New York, United States

East Carolina University - Brody School of Medicine /ID# 233062; 🇺🇸 Greenville, North Carolina, United States

PMG Research of Piedmont Healthcare-Statesville /ID# 233162; 🇺🇸 Statesville, North Carolina, United States

Univ Oklahoma HSC /ID# 233067; 🇺🇸 Oklahoma City, Oklahoma, United States

IPS Research Company /ID# 233081; 🇺🇸 Oklahoma City, Oklahoma, United States

Frontier Clinical Research, LLC - Scottdale /ID# 233129; 🇺🇸 Scottdale, Pennsylvania, United States

Frontier Clinical Research /ID# 233116; 🇺🇸 Smithfield, Pennsylvania, United States

Rhode Island Hospital /ID# 233112; 🇺🇸 Providence, Rhode Island, United States

Coastal Pediatric Research - West Ashley B /ID# 232816; 🇺🇸 Charleston, South Carolina, United States

Vinnytsya National Medical University Departement of Pediatrics No.1 /ID# 232890; 🇺🇦 Vinnytsia, Cherkaska Oblast, Ukraine

Communal Nonprofit Enterprise City Childrens Clinical Hospital 6 of Dnipro C /ID# 232863; 🇺🇦 Dnipro, Ukraine

William Harvey Hospital /ID# 232806; 🇬🇧 Ashford, Kent, United Kingdom

Coastal Pediatric Research - Summerville /ID# 232814; 🇺🇸 Summerville, South Carolina, United States

The Jackson Clinic, PA /ID# 232998; 🇺🇸 Jackson, Tennessee, United States

Accellacare of Knoxville /ID# 232663; 🇺🇸 Jefferson City, Tennessee, United States

Monroe-Carell Jr. Children's Hospital at Vanderbilt /ID# 232659; 🇺🇸 Nashville, Tennessee, United States

Oak Cliff Research Company LLC /ID# 232729; 🇺🇸 Dallas, Texas, United States

Cook Children's Med. Center /ID# 233066; 🇺🇸 Fort Worth, Texas, United States

Valley Institute of Research /ID# 232674; 🇺🇸 Harlingen, Texas, United States

Vilo Research Group Inc /ID# 233155; 🇺🇸 Houston, Texas, United States

Cullen Research /ID# 232726; 🇺🇸 Houston, Texas, United States

Synergy Group US LLC /ID# 232669; 🇺🇸 Houston, Texas, United States

Pioneer Research Solutions - Houston /ID# 233006; 🇺🇸 Houston, Texas, United States

Synergy Group US LLC /ID# 232670; 🇺🇸 Missouri City, Texas, United States

AIM Trials /ID# 232934; 🇺🇸 Plano, Texas, United States

Sun Research Institute /ID# 233005; 🇺🇸 San Antonio, Texas, United States

ClinPoint Trials /ID# 232978; 🇺🇸 Waxahachie, Texas, United States

Chrysalis Clinical Research /ID# 232690; 🇺🇸 Saint George, Utah, United States

Office of Maria Ona /ID# 232700; 🇺🇸 Franklin, Virginia, United States

Health Research of Hampton Roads, Inc. (HRHR) /ID# 233056; 🇺🇸 Newport News, Virginia, United States

Clinical Research Partners, LLC /ID# 233026; 🇺🇸 Richmond, Virginia, United States

Carilion Medical Center /ID# 232999; 🇺🇸 Roanoke, Virginia, United States

Duplicate_Multicare Institute for Research and Innovation /ID# 233010; 🇺🇸 Tacoma, Washington, United States

Marshall University Medical Center /ID# 232952; 🇺🇸 Huntington, West Virginia, United States

Duplicate_UZ Brussel /ID# 232875; 🇧🇪 Brussels, Belgium

University Hospital Plovdiv /ID# 232775; 🇧🇬 Tsentar, Plovdiv, Bulgaria

UMHAT Kanev /ID# 233102; 🇧🇬 Ruse, Smolyan, Bulgaria

Medical center 1 Sevlievo /ID# 232915; 🇧🇬 Sevlievo, Smolyan, Bulgaria

MHATSv.Ivan Rilski /ID# 232831; 🇧🇬 Kozloduy, Bulgaria

University of Alberta Hospital /ID# 233147; 🇨🇦 Edmonton, Alberta, Canada

London Health Sciences Center- University Hospital /ID# 233068; 🇨🇦 London, Ontario, Canada

Duplicate_SKDS Research Inc. /ID# 233000; 🇨🇦 Newmarket, Ontario, Canada

Bluewater Clinical Research Group Inc /ID# 232772; 🇨🇦 Sarnia, Ontario, Canada

Stouffville Medical Centre /ID# 232774; 🇨🇦 Stouffville, Ontario, Canada

Merelahe Family Doctors Centre /ID# 232881; 🇪🇪 Tallinn, Raplamaa, Estonia

Kliiniliste Uuringute Keskus /ID# 232883; 🇪🇪 Tartu, Raplamaa, Estonia

Al Mare Perearstikeskus /ID# 232879; 🇪🇪 Harjumaa, Estonia

Duplicate_Klinikum Kassel /ID# 233029; 🇩🇪 Kassel, Hessen, Germany

Duplicate_Rambam Health Care Campus Ruth Rappaport Children's Hospital /ID# 232892; 🇮🇱 Haifa, H_efa, Israel

The Edith Wolfson Medical Center /ID# 233134; 🇮🇱 Ashkelon, HaDarom, Israel

Schneider Children's Medical Center /ID# 233064; 🇮🇱 Petah Tikva, HaMerkaz, Israel

The Baruch Padeh Medical Center Poriya /ID# 232889; 🇮🇱 Tiberias, HaTsafon, Israel

The Chaim Sheba Medical Center /ID# 232986; 🇮🇱 Ramat Gan, Tel-Aviv, Israel

Shaare Zedek Medical Center /ID# 233092; 🇮🇱 Jerusalem, Yerushalayim, Israel

Hadassah Hebrew University Hospital - Ein Kerem /ID# 232865; 🇮🇱 Jerusalem, Yerushalayim, Israel

Sant?Andrea University Hospital /ID# 232825; 🇮🇹 Rome, Italy

Duplicate_Academisch Medisch Centrum /ID# 232895; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Maasstad Ziekenhuis /ID# 233003; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

Isala /ID# 233031; 🇳🇱 Zwolle, Zuid-Holland, Netherlands

Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza /ID# 232898; 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Klinika Pediatrii Gastroenterologii Alergologii i Zywienia Dzieci GUM /ID# 232900; 🇵🇱 Gdansk, Kujawsko-pomorskie, Poland

Poradnia Gastroenterologiczna /ID# 232899; 🇵🇱 Olsztyn, Kujawsko-pomorskie, Poland

Korczowski Bartosz Gabinet Lekarski /ID# 232821; 🇵🇱 Rzeszow, Kujawsko-pomorskie, Poland

San Juan Bautista School of Medicine /ID# 232913; 🇵🇷 Caguas, Puerto Rico

Instituto Hispalense Pediatria /ID# 232793; 🇪🇸 Sevilla, Spain

Kharkiv Regional Childrens Clinical Hospital Gastroent. Centre Kharkiv Natl. Me /ID# 232867; 🇺🇦 Kharkiv, Cherkaska Oblast, Ukraine

Municipal Nonprofit Enterprise Lviv City Children's Clinical Hospital /ID# 232851; 🇺🇦 Lviv, Cherkaska Oblast, Ukraine

Central Research Associates /ID# 233124; 🇺🇸 Birmingham, Alabama, United States

G & L Research, LLC /ID# 233139; 🇺🇸 Foley, Alabama, United States

The Center for Clinical Trials Inc. /ID# 232755; 🇺🇸 Saraland, Alabama, United States

HealthStar Research of Hot Springs PLLC /ID# 232757; 🇺🇸 Hot Springs, Arkansas, United States

Preferred Research Partners /ID# 233023; 🇺🇸 Little Rock, Arkansas, United States

Applied Research Center of Arkansas /ID# 233135; 🇺🇸 Little Rock, Arkansas, United States

Advanced Research Center /ID# 233121; 🇺🇸 Anaheim, California, United States

Alliance Research Institute /ID# 232754; 🇺🇸 Bell Gardens, California, United States

Alliance Research Institute Llc /Id# 232637; 🇺🇸 Canoga Park, California, United States

Kindred Medical Institute, LLC /ID# 233042; 🇺🇸 Corona, California, United States

Center for Clinical Trials LLC /ID# 232781; 🇺🇸 Paramount, California, United States

Medical Ctr for Clin Research /ID# 233004; 🇺🇸 San Diego, California, United States

Paragon Rx Clinical Inc /ID# 232752; 🇺🇸 Santa Ana, California, United States

Lynn Institute of Denver /ID# 233137; 🇺🇸 Aurora, Colorado, United States

Children's National Medical Center /ID# 232655; 🇺🇸 Washington, District of Columbia, United States

Prohealth Research Center /ID# 232805; 🇺🇸 Doral, Florida, United States

Dolphin Medical Research /ID# 232815; 🇺🇸 Doral, Florida, United States

Amedica Research Institute Inc /ID# 232809; 🇺🇸 Hialeah, Florida, United States

Nemours Children's Health System /ID# 233127; 🇺🇸 Jacksonville, Florida, United States

Elite Clinical Research /ID# 232801; 🇺🇸 Miami, Florida, United States

My Preferred Research LLC /ID# 233119; 🇺🇸 Miami, Florida, United States

South Miami Medical & Research Group Inc. /ID# 232803; 🇺🇸 Miami, Florida, United States

Valencia Medical & Research Center /ID# 232813; 🇺🇸 Miami, Florida, United States

Advanced Research for Health Improvement /ID# 233161; 🇺🇸 Naples, Florida, United States

Pediatric & Adult Research Center /ID# 232819; 🇺🇸 Orlando, Florida, United States

Nemours Children's Hospital /ID# 232919; 🇺🇸 Orlando, Florida, United States

Oviedo Medical Research /ID# 232830; 🇺🇸 Oviedo, Florida, United States

Treken Primary Care /ID# 232796; 🇺🇸 Atlanta, Georgia, United States

Children's Healthcare of Atlanta - Ferry Rd /ID# 233015; 🇺🇸 Atlanta, Georgia, United States

Children's Ctr Digestive, US /ID# 233070; 🇺🇸 Atlanta, Georgia, United States

River Birch Research Alliance /ID# 233122; 🇺🇸 Blue Ridge, Georgia, United States

Clinical Research Institute /ID# 232833; 🇺🇸 Stockbridge, Georgia, United States

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 232940; 🇺🇸 Stockbridge, Georgia, United States

Clinical Trials Specialist Inc /ID# 232802; 🇺🇸 Stone Mountain, Georgia, United States

Rophe Adult and Pediatric Medicine/SKYCRNG /ID# 232800; 🇺🇸 Union City, Georgia, United States

Univ Kansas Med Ctr /ID# 232645; 🇺🇸 Kansas City, Kansas, United States

Alliance for Multispecialty Research LLC /ID# 232681; 🇺🇸 Newton, Kansas, United States

Michael W. Simon, MD, PSC /ID# 232966; 🇺🇸 Lexington, Kentucky, United States

Meridian Research - Baton Rouge /ID# 232954; 🇺🇸 Baton Rouge, Louisiana, United States

Virgo Carter Pediatrics /ID# 232693; 🇺🇸 Silver Spring, Maryland, United States

MNGI Digestive Health, P. A. /ID# 232920; 🇺🇸 Minneapolis, Minnesota, United States

GI associates and Endoscopy Ce /ID# 233123; 🇺🇸 Flowood, Mississippi, United States

David M. Headley, MD, P.A. /ID# 233153; 🇺🇸 Port Gibson, Mississippi, United States

Private Practice - Dr. Craig Spiegel /ID# 232707; 🇺🇸 Bridgeton, Missouri, United States