Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection
- Conditions
- Helicobacter Pylori Infection
- Interventions
- Registration Number
- NCT04167670
- Lead Sponsor
- Phathom Pharmaceuticals, Inc.
- Brief Summary
To compare the efficacy of Helicobacter pylori (HP) eradication with vonoprazan dual and triple therapy regimens versus lansoprazole triple therapy regimen in participants with HP infection, excluding participants who had a clarithromycin or amoxicillin resistant strain of HP at baseline.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1046
-
The participant is ≥ 18 years of age at the time of informed consent signing.
-
In the opinion of the investigator or sub-investigators, the participant is capable of understanding and complying with protocol requirements.
-
The participant signs and dates a written, informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side-effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
-
The participant has at least one of the following clinical conditions with confirmed HP+ infection demonstrated by a positive 13C-UBT during the Screening Period.
- Dyspepsia (i.e. pain or discomfort centered in the upper abdomen) lasting at least 2 weeks
- A confirmed diagnosis of functional dyspepsia
- A recent / new diagnosis of (non-bleeding) peptic ulcer
- A history of peptic ulcer not previously treated for HP infection
- A requirement for long-term non-steroidal anti-inflammatory drug (NSAID) treatment at a stable dose of the NSAID
-
A female participant of childbearing potential who is or may be routinely sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until Day -2 and two forms of adequate contraception from Day -1 until 4 weeks after the last dose of study drug.
-
The participant has previously been treated with any regimen to attempt to eradicate HP.
-
The participant has gastric or duodenal ulcer with endoscopic evidence of current or recent bleeding.
-
The participant has confirmed diagnosis of gastric cancer by biopsy.
-
The participant is receiving colchicine.
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The participant has received any investigational compound (including those in post marketing studies) within 30 days prior to the start of the Screening Period. A participant who has screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
-
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or who may have consented under duress.
-
The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
-
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
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The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
-
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, red or yellow ferric oxide), PPIs, amoxicillin and/or clarithromycin, or any excipients used in the 13C-UBT: mannitol, citric acid or aspartame. Skin testing may be performed according to local standard practice to confirm hypersensitivity.
-
The participant has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or who regularly consume >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Participants must have a negative urine drug screen for cannabinoids/ tetrahydrocannabinol and non-prescribed medications at screening.
-
The participant is taking any excluded medications or treatments listed in the protocol.
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If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study; or intending to donate ova during such time period.
-
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participants safety.
-
The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
-
The participant has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1) (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
-
The participant has acquired immunodeficiency syndrome or human immunodeficiency virus infection, or tests positive for the hepatitis B surface antigen, hepatitis C virus (HCV) antibody or HCV RNA. However, participants who test positive for HCV antibody, but negative for HCV RNA are permitted to participate.
-
The participant has any of the following abnormal laboratory test values at the start of the Screening Period:
- Creatinine levels: >2 mg/dL (>177 μmol/L).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vonoprazan triple therapy Amoxicillin Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days. Vonoprazan triple therapy Vonoprazan Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days. Vonoprazan dual therapy Vonoprazan Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days. Vonoprazan dual therapy Amoxicillin Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days. Vonoprazan triple therapy Clarithromycin Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days. Lansoprazole triple therapy Amoxicillin Participants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days. Lansoprazole triple therapy Clarithromycin Participants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days. Lansoprazole triple therapy Lansoprazole Participants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks) H pylori eradication was determined by the \^13C-UBT test.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants With a Clarithromycin-resistant Strain of H Pylori at Baseline Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks) H pylori eradication was determined by the \^13C-UBT test.
Percentage of All Participants With Successful Helicobacter Pylori (H Pylori) Eradication Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks) H pylori eradication was determined by the \^13C-UBT test.
Trial Locations
- Locations (150)
Carolina Research
🇺🇸Greenville, North Carolina, United States
Synexus Clinical Research US, Inc. - Anderson
🇺🇸Anderson, South Carolina, United States
Anaheim Clinical Trials LLC
🇺🇸Anaheim, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
🇺🇸Lancaster, California, United States
Southern California Research Institute Medical Group, Inc.
🇺🇸Los Angeles, California, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Gastroenterology Associates of Fairfield County
🇺🇸Bridgeport, Connecticut, United States
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
Verity Research, Inc.
🇺🇸Fairfax, Virginia, United States
Jesscan Medical Research
🇺🇸Miami, Florida, United States
Nuren Medical and Research Center
🇺🇸Miami, Florida, United States
Premier Research Associate-Miami
🇺🇸Miami, Florida, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Office - Site 2
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Clinical Research Associates Inc
🇺🇸Nashville, Tennessee, United States
San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
🇺🇸San Antonio, Texas, United States
Southern Star Research Institute, LLC
🇺🇸San Antonio, Texas, United States
Synexus - Midlands Clinical Research Centre
🇬🇧Edgbaston, United Kingdom
Synexus - Lancashire Clinical Research Centre
🇬🇧Chorley, United Kingdom
Synexus - Merseyside Clinical Research Centre
🇬🇧Liverpool, United Kingdom
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
🇺🇸Mesa, Arizona, United States
Applied Research Center of Little Rock
🇺🇸Little Rock, Arkansas, United States
North Alabama Research Center, LLC
🇺🇸Athens, Alabama, United States
Precision Research Institute
🇺🇸San Diego, California, United States
Preferred Research Partners - ClinEdge - PPDS
🇺🇸Little Rock, Arkansas, United States
Connecticut Clinical Research Foundation
🇺🇸Bristol, Connecticut, United States
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
🇺🇸Chandler, Arizona, United States
Kindred Medical Institute for Clinical Trials, LLC
🇺🇸Corona, California, United States
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
🇺🇸Mesa, Arizona, United States
HB Clinical Trials, Inc.
🇺🇸Fountain Valley, California, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Atria Clinical Research - BTC - PPDS
🇺🇸North Little Rock, Arkansas, United States
Advanced Gastroenterology Associates, LLC
🇺🇸Palm Harbor, Florida, United States
In Quest Medical Research - ClinEdge - PPDS
🇺🇸Peachtree Corners, Georgia, United States
Oakland Medical Research Center
🇺🇸Troy, Michigan, United States
Quality Research Inc
🇺🇸San Antonio, Texas, United States
University of Utah Hospital- Health Sciences Center - PPDS
🇺🇸Salt Lake City, Utah, United States
Synexus Clinical Research US, Inc. - Layton
🇺🇸Layton, Utah, United States
Diagnostic and Consulting Center Aleksandrovska EOOD
🇧🇬Sofia, Bulgaria
PreventaMed s.r.o.
🇨🇿Olomouc, Czechia
Synexus Clinical Research US, Inc. - Site 1
🇺🇸Henderson, Nevada, United States
Sierra Clinical Research - ClinEdge - PPDS
🇺🇸Las Vegas, Nevada, United States
Prestige Clinical Research
🇺🇸Franklin, Ohio, United States
Dayton Gastroenterology, Inc
🇺🇸Dayton, Ohio, United States
Multi Specialty Clinical Research
🇺🇸Johnson City, Tennessee, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Digestive System Healthcare
🇺🇸Pasadena, Texas, United States
Gastroenterology Research of San Antonio (GERSA)
🇺🇸San Antonio, Texas, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
University Multiprofile Hospital for Active Treatment
🇧🇬Pleven, Bulgaria
Second Multiprofile Hospital for Active Treatment Sofia
🇧🇬Sofia, Bulgaria
Synexus Czech s.r.o.
🇨🇿Prague, Czechia
MEDIC KRAL s.r.o.
🇨🇿Praha, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie
🇨🇿Ústí Nad Labem, Czechia
Synexus (DRS) - Synexus Magyarország Kft. Budapest
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Synexus - Katowice
🇵🇱Katowice, Poland
CPS Research
🇬🇧Glasgow, United Kingdom
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
🇵🇱Ksawerów, Poland
Synexus - Warsaw
🇵🇱Warszawa, Poland
Synexus - Poznan
🇵🇱Poznań, Poland
Synexus - Lodz
🇵🇱Łódź, Poland
Synexus - Manchester Clinical Research Centre
🇬🇧Manchester, United Kingdom
Synexus Thames Valley Clinical Research Centre
🇬🇧Reading, United Kingdom
Synexus - North Tees Clinical Research Centre
🇬🇧Stockton-on-Tees, United Kingdom
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Medical Affiliated Research Center Inc
🇺🇸Huntsville, Alabama, United States
Multiprofile Hospital for Active Treatment Puls AD - PPDS
🇧🇬Blagoevgrad, Bulgaria
Medical Center Excelsior OOD - PPDS
🇧🇬Sofia, Bulgaria
Fourth Multiprofile Hospital for Active Treatment
🇧🇬Sofia, Bulgaria
Diagnostic- Consultative Center Convex EOOD
🇧🇬Sofia, Bulgaria
Synexus - Medical Center Synexus Sofia EOOD
🇧🇬Sofia, Bulgaria
Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)
🇧🇬Stara Zagora, Bulgaria
Synexus Clinical Research US, Inc.
🇺🇸Colorado Springs, Colorado, United States
Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
🇭🇺Gyula, Hungary
Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg
🇭🇺Zalaegerszeg, Hungary
Del Sol Research Management - BTC - PPDS
🇺🇸Tucson, Arizona, United States
Office - Site 1
🇺🇸Las Vegas, Nevada, United States
ENCORE Borland-Groover Clinical Research - ERN - PPDS
🇺🇸Jacksonville, Florida, United States
Columbus Clinical Services LLC
🇺🇸Miami, Florida, United States
Summit Digestive & Liver Disease Specialists
🇺🇸Oakbrook Terrace, Illinois, United States
Paragon Rx Clinical, Inc.
🇺🇸Santa Ana, California, United States
Torrance Clinical Research Institute
🇺🇸Lomita, California, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Pearland Physicians
🇺🇸Pearland, Texas, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
eStudySite - Chula Vista - PPDS
🇺🇸Chula Vista, California, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Palmtree Clinical Research
🇺🇸Palm Springs, California, United States
Western States Clinical Research, Inc.
🇺🇸Wheat Ridge, Colorado, United States
Research Centers of America - ERG
🇺🇸Hollywood, Florida, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Innovation Medical Research Center
🇺🇸Palmetto Bay, Florida, United States
Synexus Clinical Research US, Inc. - St. Petersburg
🇺🇸Pinellas Park, Florida, United States
Precision Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Gastroenterology Associates of Central Georgia, LLC
🇺🇸Macon, Georgia, United States
Nexgen Research Center
🇺🇸Atlanta, Georgia, United States
Clinical Trials Management LLC
🇺🇸Metairie, Louisiana, United States
CroNOLA, LLC.
🇺🇸Houma, Louisiana, United States
Meridian Clinical Research-(Rockville Maryland)
🇺🇸Rockville, Maryland, United States
Clinical Associates
🇺🇸Towson, Maryland, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Synexus Clinical Research US, Inc. - Site 2
🇺🇸Henderson, Nevada, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Drug Trials America - ClinEdge
🇺🇸Hartsdale, New York, United States
Carolinas Research Center
🇺🇸Charlotte, North Carolina, United States
Medication Management LLC
🇺🇸Greensboro, North Carolina, United States
Peters Medical Research, LLC - ClinEdge - PPDS
🇺🇸High Point, North Carolina, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Rapid City Medical Center LLP
🇺🇸Rapid City, South Dakota, United States
Inquest Clinical Research
🇺🇸Baytown, Texas, United States
Synexus Clinical Research US, Inc. - Dallas
🇺🇸Dallas, Texas, United States
Texas Tech University Health Sciences Center El Paso
🇺🇸El Paso, Texas, United States
Precision Research Institute, LLC
🇺🇸Houston, Texas, United States
Rio Grande Gastroenterology
🇺🇸McAllen, Texas, United States
Synexus Clinical Research US, Inc. - Plano
🇺🇸Plano, Texas, United States
Washington Gastroenterology
🇺🇸Bellevue, Washington, United States
Blue Ridge Medical Research
🇺🇸Lynchburg, Virginia, United States
Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni
🇨🇿Ústí Nad Orlicí, Czechia
Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen
🇭🇺Debrecen, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
🇵🇱Bydgoszcz, Poland
Synexus - Gdansk
🇵🇱Gdańsk, Poland
Synexus Affiliate BKS Research Kft. Hatvan
🇭🇺Hatvan, Hungary
Synexus - Czestochowa
🇵🇱Czestochowa, Poland
Gabinet Lekarski-Janusz Rudzinski
🇵🇱Bydgoszcz, Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
🇵🇱Szczecin, Poland
Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii
🇵🇱Toruń, Poland
Korczowski Bartosz, Gabinet Lekarski
🇵🇱Rzeszów, Poland
Synexus - Wroclaw
🇵🇱Wrocław, Poland
Synexus - Wales Clinical Research Centre
🇬🇧Cardiff, United Kingdom
Synexus - Hexham Clinical Research Centre
🇬🇧Hexham, United Kingdom
Synexus Affiliate - Krakowskie Centrum Medyczne
🇵🇱Kraków, Poland
Synexus - Gdynia
🇵🇱Gdynia, Poland
Melita Medical
🇵🇱Wrocław, Poland
Santa Familia Centrum Badań Profilaktyki i Leczenia
🇵🇱Łódź, Poland
Synexus Clinical Research US, Inc. - Alabama
🇺🇸Birmingham, Alabama, United States
Hope Research Institute LLC
🇺🇸Phoenix, Arizona, United States
Elite Clinical Studies - Phoenix - BTC - PPDS
🇺🇸Phoenix, Arizona, United States
G. Medical Center
🇺🇸Orlando, Florida, United States
Guardian Angel Research Center
🇺🇸Tampa, Florida, United States
The Alliance for Multispecialty Research, LLC
🇺🇸Kansas City, Missouri, United States
Heartland Clinical Research, Inc
🇺🇸Omaha, Nebraska, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
GW Research, Inc. - ClinEdge - PPDS
🇺🇸Chula Vista, California, United States
IL Gastroenterology Group
🇺🇸Gurnee, Illinois, United States
Gastroenterology Health Partners, PLLC
🇺🇸New Albany, Indiana, United States