Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection
A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy With Oral Vonoprazan 20 mg or Double-Blind Triple Therapy With Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy With Oral Lansoprazole 30 mg Daily in Patients With Helicobacter Pylori Infection
2 other identifiers
interventional
1,046
6 countries
153
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2019
Shorter than P25 for phase_3
153 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedStudy Start
First participant enrolled
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2021
CompletedResults Posted
Study results publicly available
April 5, 2022
CompletedApril 5, 2022
March 1, 2022
1.2 years
November 15, 2019
March 9, 2022
March 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Successful Helicobacter Pylori (H Pylori) Eradication in Participants Without a Clarithromycin- or Amoxicillin-resistant Strain of H Pylori at Baseline
H pylori eradication was determined by the \^13C-UBT test.
Baseline to 4 weeks after the last dose of study drugs (maximum duration of treatment was 2 weeks)
Secondary Outcomes (2)
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)
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)
Study Arms (3)
Vonoprazan dual therapy
EXPERIMENTALParticipants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days.
Vonoprazan triple therapy
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days.
Interventions
Over-encapsulated tablets administered orally.
Capsules administered orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (153)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
North Alabama Research Center, LLC
Athens, Alabama, 35611, United States
Synexus Clinical Research US, Inc. - Alabama
Birmingham, Alabama, 35211, United States
Medical Affiliated Research Center Inc
Huntsville, Alabama, 35801, United States
Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC
Chandler, Arizona, 85224, United States
Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC
Mesa, Arizona, 85206, United States
Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC
Mesa, Arizona, 85213, United States
Elite Clinical Studies - Phoenix - BTC - PPDS
Phoenix, Arizona, 85018, United States
Hope Research Institute LLC
Phoenix, Arizona, 85018, United States
Del Sol Research Management - BTC - PPDS
Tucson, Arizona, 85712, United States
Preferred Research Partners - ClinEdge - PPDS
Little Rock, Arkansas, 72211, United States
Applied Research Center of Little Rock
Little Rock, Arkansas, 72212, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
Atria Clinical Research - BTC - PPDS
North Little Rock, Arkansas, 72117, United States
Anaheim Clinical Trials LLC
Anaheim, California, 92801, United States
GW Research, Inc. - ClinEdge - PPDS
Chula Vista, California, 91910, United States
eStudySite - Chula Vista - PPDS
Chula Vista, California, 91911, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
HB Clinical Trials, Inc.
Fountain Valley, California, 92708-7510, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, 93534, United States
Torrance Clinical Research Institute
Lomita, California, 90717, United States
Southern California Research Institute Medical Group, Inc.
Los Angeles, California, 90045, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Palmtree Clinical Research
Palm Springs, California, 92262, United States
Precision Research Institute
San Diego, California, 92114, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Paragon Rx Clinical, Inc.
Santa Ana, California, 92703, United States
Synexus Clinical Research US, Inc.
Colorado Springs, Colorado, 80909, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033, United States
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, 06606, United States
Connecticut Clinical Research Foundation
Bristol, Connecticut, 06010, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Research Centers of America - ERG
Hollywood, Florida, 33024, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
ENCORE Borland-Groover Clinical Research - ERN - PPDS
Jacksonville, Florida, 32256, United States
Columbus Clinical Services LLC
Miami, Florida, 33125, United States
Jesscan Medical Research
Miami, Florida, 33134, United States
Nuren Medical and Research Center
Miami, Florida, 33144, United States
Premier Research Associate-Miami
Miami, Florida, 33165, United States
G. Medical Center
Orlando, Florida, 32807, United States
Advanced Gastroenterology Associates, LLC
Palm Harbor, Florida, 34684, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 33157, United States
Synexus Clinical Research US, Inc. - St. Petersburg
Pinellas Park, Florida, 33781, United States
Precision Clinical Research, LLC
Sunrise, Florida, 33351, United States
Guardian Angel Research Center
Tampa, Florida, 33614, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Nexgen Research Center
Atlanta, Georgia, 30345, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201, United States
In Quest Medical Research - ClinEdge - PPDS
Peachtree Corners, Georgia, 30071, United States
IL Gastroenterology Group
Gurnee, Illinois, 60031, United States
Summit Digestive & Liver Disease Specialists
Oakbrook Terrace, Illinois, 60181, United States
Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150, United States
Iowa Digestive Disease Center
Clive, Iowa, 50325, United States
Clinical Trials Management LLC
Covington, Louisiana, 70433, United States
CroNOLA, LLC.
Houma, Louisiana, 70360, United States
Clinical Trials Management LLC
Metairie, Louisiana, 70006, United States
Meridian Clinical Research-(Rockville Maryland)
Rockville, Maryland, 20854, United States
Clinical Associates
Towson, Maryland, 21286, United States
Oakland Medical Research Center
Troy, Michigan, 48085, United States
The Alliance for Multispecialty Research, LLC
Kansas City, Missouri, 64114, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Heartland Clinical Research, Inc
Omaha, Nebraska, 68134, United States
Synexus Clinical Research US, Inc. - Site 1
Henderson, Nevada, 89052, United States
Synexus Clinical Research US, Inc. - Site 2
Henderson, Nevada, 89052, United States
Sierra Clinical Research - ClinEdge - PPDS
Las Vegas, Nevada, 89106, United States
Office - Site 1
Las Vegas, Nevada, 89119, United States
Office - Site 2
Las Vegas, Nevada, 89128, United States
Advanced Research Institute
Reno, Nevada, 89511, United States
Drug Trials America - ClinEdge
Hartsdale, New York, 10530, United States
Carolinas Research Center
Charlotte, North Carolina, 28215, United States
Duke University Medical Center
Durham, North Carolina, 27710-4000, United States
Medication Management LLC
Greensboro, North Carolina, 27408, United States
Carolina Research
Greenville, North Carolina, 27834, United States
Peters Medical Research, LLC - ClinEdge - PPDS
High Point, North Carolina, 27262, United States
Dayton Gastroenterology, Inc
Dayton, Ohio, 45415, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Synexus Clinical Research US, Inc. - Anderson
Anderson, South Carolina, 29621, United States
Clinical Trials of South Carolina
Charleston, South Carolina, 29406, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Rapid City Medical Center LLP
Rapid City, South Dakota, 57701, United States
Multi Specialty Clinical Research
Johnson City, Tennessee, 37601, United States
Clinical Research Associates Inc
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Inquest Clinical Research
Baytown, Texas, 77521, United States
Synexus Clinical Research US, Inc. - Dallas
Dallas, Texas, 75234, United States
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, 79905, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Precision Research Institute, LLC
Houston, Texas, 77036, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Rio Grande Gastroenterology
McAllen, Texas, 78503, United States
Digestive System Healthcare
Pasadena, Texas, 77505, United States
Pearland Physicians
Pearland, Texas, 77581, United States
Synexus Clinical Research US, Inc. - Plano
Plano, Texas, 75093, United States
Quality Research Inc
San Antonio, Texas, 78209, United States
Gastroenterology Research of San Antonio (GERSA)
San Antonio, Texas, 78229, United States
San Antonio Gastroenterology Associates Clinical Trials (SAGACT PLLC)
San Antonio, Texas, 78229, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Synexus Clinical Research US, Inc. - Layton
Layton, Utah, 84041, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
University of Utah Hospital- Health Sciences Center - PPDS
Salt Lake City, Utah, 84132-0001, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
Verity Research, Inc.
Fairfax, Virginia, 22031, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Washington Gastroenterology
Bellevue, Washington, 98004, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Multiprofile Hospital for Active Treatment Puls AD - PPDS
Blagoevgrad, 2700, Bulgaria
University Multiprofile Hospital for Active Treatment
Pleven, 5800, Bulgaria
Second Multiprofile Hospital for Active Treatment Sofia
Sofia, 1202, Bulgaria
Medical Center Excelsior OOD - PPDS
Sofia, 1407, Bulgaria
Diagnostic and Consulting Center Aleksandrovska EOOD
Sofia, 1431, Bulgaria
Fourth Multiprofile Hospital for Active Treatment
Sofia, 1606, Bulgaria
Diagnostic- Consultative Center Convex EOOD
Sofia, 1680, Bulgaria
Synexus - Medical Center Synexus Sofia EOOD
Sofia, 1784, Bulgaria
Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)
Stara Zagora, 6003, Bulgaria
PreventaMed s.r.o.
Olomouc, 779 00, Czechia
Synexus Czech s.r.o.
Prague, 120 00, Czechia
MEDIC KRAL s.r.o.
Prague, 190 00, Czechia
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie
Ústí nad Labem, 401 13, Czechia
Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni
Ústí nad Orlicí, 562 18, Czechia
Synexus (DRS) - Synexus Magyarország Kft. Budapest
Budapest, 1036, Hungary
Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen
Debrecen, 4025, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Synexus (DRS) - Synexus Magyarorszag Kft. Gyula
Gyula, 5700, Hungary
Synexus Affiliate BKS Research Kft. Hatvan
Hatvan, 3000, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400, Hungary
Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg
Zalaegerszeg, 8900, Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
Bydgoszcz, 85-168, Poland
Gabinet Lekarski-Janusz Rudzinski
Bydgoszcz, 85-681, Poland
Synexus - Czestochowa
Częstochowa, 42-202, Poland
Synexus - Gdansk
Gdansk, 80-382, Poland
Synexus - Gdynia
Gdynia, 81-537, Poland
Synexus - Katowice
Katowice, 40-040, Poland
Synexus Affiliate - Krakowskie Centrum Medyczne
Krakow, 31-501, Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054, Poland
Synexus - Lodz
Lodz, 90-127, Poland
Santa Familia Centrum Badań Profilaktyki i Leczenia
Lodz, 90-302, Poland
Synexus - Poznan
Poznan, 60-702, Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
Twoja Przychodnia - Szczecińskie Centrum Medyczne
Szczecin, 71-434, Poland
Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, 87-100, Poland
Synexus - Warsaw
Warsaw, 01-192, Poland
Synexus - Wroclaw
Wroclaw, 50-381, Poland
Melita Medical
Wroclaw, 50-449, Poland
Synexus - Wales Clinical Research Centre
Cardiff, CF15 9SS, United Kingdom
Synexus - Lancashire Clinical Research Centre
Chorley, PR7 7NA, United Kingdom
Synexus - Midlands Clinical Research Centre
Edgbaston, B15 2SQ, United Kingdom
CPS Research
Glasgow, G20 0XA, United Kingdom
Synexus - Hexham Clinical Research Centre
Hexham, NE46 1QJ, United Kingdom
Synexus - Merseyside Clinical Research Centre
Liverpool, L22 0LG, United Kingdom
Synexus - Manchester Clinical Research Centre
Manchester, M15 6SE, United Kingdom
Synexus Thames Valley Clinical Research Centre
Reading, RG2 0TG, United Kingdom
Synexus - North Tees Clinical Research Centre
Stockton-on-Tees, TS19 8PE, United Kingdom
Related Publications (2)
Megraud F, Graham DY, Howden CW, Trevino E, Weissfeld A, Hunt B, Smith N, Leifke E, Chey WD. Rates of Antimicrobial Resistance in Helicobacter pylori Isolates From Clinical Trial Patients Across the US and Europe. Am J Gastroenterol. 2023 Feb 1;118(2):269-275. doi: 10.14309/ajg.0000000000002045. Epub 2022 Sep 30.
PMID: 36191284DERIVEDChey WD, Megraud F, Laine L, Lopez LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022 Sep;163(3):608-619. doi: 10.1053/j.gastro.2022.05.055. Epub 2022 Jun 6.
PMID: 35679950DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Phathom Medical Information
- Organization
- Phathom Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Phathom Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The triple therapy arms will be blinded to participants, care providers, investigators and outcome assessors. The dual therapy arm will only blinded to the outcomes assessor.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2019
First Posted
November 19, 2019
Study Start
December 10, 2019
Primary Completion
March 10, 2021
Study Completion
March 18, 2021
Last Updated
April 5, 2022
Results First Posted
April 5, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share