Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Helicobacter Pylori Infection

NCT ID: NCT04167670

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1046 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2021-03-18

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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vonoprazan dual therapy

Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g, three times daily, for 14 days.

Group Type: EXPERIMENTAL

Vonoprazan

Intervention Type: DRUG

Over-encapsulated tablets administered orally.

Amoxicillin

Intervention Type: DRUG

Capsules administered orally.

Vonoprazan triple therapy

Participants will receive vonoprazan 20 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg, BID, for 14 days.

Group Type: EXPERIMENTAL

Vonoprazan

Intervention Type: DRUG

Over-encapsulated tablets administered orally.

Amoxicillin

Intervention Type: DRUG

Capsules administered orally.

Clarithromycin

Intervention Type: DRUG

Tablets administered orally.

Lansoprazole triple therapy

Participants will receive lansoprazole 30 mg twice daily (BID) in conjunction with amoxicillin 1 g BID and clarithromycin 500 mg BID, for 14 days.

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

Capsules administered orally.

Clarithromycin

Intervention Type: DRUG

Tablets administered orally.

Lansoprazole

Intervention Type: DRUG

Over-encapsulated capsules administered orally.

Interventions

Vonoprazan

Over-encapsulated tablets administered orally.

Intervention Type: DRUG

Amoxicillin

Capsules administered orally.

Intervention Type: DRUG

Clarithromycin

Tablets administered orally.

Intervention Type: DRUG

Lansoprazole

Over-encapsulated capsules administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The participant is ≥ 18 years of age at the time of informed consent signing.

2. In the opinion of the investigator or sub-investigators, the participant is capable of understanding and complying with protocol requirements.

3. 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.

4. 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

5. 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.

Exclusion Criteria

1. The participant has previously been treated with any regimen to attempt to eradicate HP.

2. The participant has gastric or duodenal ulcer with endoscopic evidence of current or recent bleeding.

3. The participant has confirmed diagnosis of gastric cancer by biopsy.

4. The participant is receiving colchicine.

5. 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.

6. 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.

7. The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.

8. The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.

9. The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.

10. 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.

11. 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.

12. The participant is taking any excluded medications or treatments listed in the protocol.

13. 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.

14. 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.

15. 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.

16. 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).

17. 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.

18. The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

1. Creatinine levels: >2 mg/dL (>177 μmol/L).

2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phathom Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Phathom Pharmaceuticals

Locations

Pinnacle Research Group

Anniston, Alabama, United States

North Alabama Research Center, LLC

Athens, Alabama, United States

Synexus Clinical Research US, Inc. - Alabama

Birmingham, Alabama, United States

Medical Affiliated Research Center Inc

Huntsville, Alabama, United States

Synexus Clinical Research US, Inc. - East Valley Family Physicians, PLC

Chandler, Arizona, United States

Synexus Clinical Research US, Inc. - Central Arizona Medical Associates, PC

Mesa, Arizona, United States

Synexus Clinical Research US, Inc. - Desert Clinical Research, LLC

Mesa, Arizona, United States

Elite Clinical Studies - Phoenix - BTC - PPDS

Phoenix, Arizona, United States

Hope Research Institute LLC

Phoenix, Arizona, United States

Del Sol Research Management - BTC - PPDS

Tucson, Arizona, United States

Preferred Research Partners - ClinEdge - PPDS

Little Rock, Arkansas, United States

Applied Research Center of Little Rock

Little Rock, Arkansas, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Atria Clinical Research - BTC - PPDS

North Little Rock, Arkansas, United States

Anaheim Clinical Trials LLC

Anaheim, California, United States

GW Research, Inc. - ClinEdge - PPDS

Chula Vista, California, United States

eStudySite - Chula Vista - PPDS

Chula Vista, California, United States

Kindred Medical Institute for Clinical Trials, LLC

Corona, California, United States

HB Clinical Trials, Inc.

Fountain Valley, California, United States

OM Research LLC - Lancaster - ClinEdge - PPDS

Lancaster, California, United States

Torrance Clinical Research Institute

Lomita, California, United States

Southern California Research Institute Medical Group, Inc.

Los Angeles, California, United States

Facey Medical Foundation

Mission Hills, California, United States

Palmtree Clinical Research

Palm Springs, California, United States

Precision Research Institute

San Diego, California, United States

Medical Associates Research Group, Inc.

San Diego, California, United States

Paragon Rx Clinical, Inc.

Santa Ana, California, United States

Synexus Clinical Research US, Inc.

Colorado Springs, Colorado, United States

Western States Clinical Research, Inc.

Wheat Ridge, Colorado, United States

Gastroenterology Associates of Fairfield County

Bridgeport, Connecticut, United States

Connecticut Clinical Research Foundation

Bristol, Connecticut, United States

Riverside Clinical Research

Edgewater, Florida, United States

Research Centers of America - ERG

Hollywood, Florida, United States

Nature Coast Clinical Research

Inverness, Florida, United States

ENCORE Borland-Groover Clinical Research - ERN - PPDS

Jacksonville, Florida, United States

Columbus Clinical Services LLC

Miami, Florida, 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

G. Medical Center

Orlando, Florida, United States

Advanced Gastroenterology Associates, LLC

Palm Harbor, 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

Guardian Angel Research Center

Tampa, Florida, United States

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Nexgen Research Center

Atlanta, Georgia, United States

Gastroenterology Associates of Central Georgia, LLC

Macon, Georgia, United States

In Quest Medical Research - ClinEdge - PPDS

Peachtree Corners, Georgia, United States

IL Gastroenterology Group

Gurnee, Illinois, United States

Summit Digestive & Liver Disease Specialists

Oakbrook Terrace, Illinois, United States

Gastroenterology Health Partners, PLLC

New Albany, Indiana, United States

Iowa Digestive Disease Center

Clive, Iowa, United States

Clinical Trials Management LLC

Covington, Louisiana, United States

CroNOLA, LLC.

Houma, Louisiana, United States

Clinical Trials Management LLC

Metairie, Louisiana, United States

Meridian Clinical Research-(Rockville Maryland)

Rockville, Maryland, United States

Clinical Associates

Towson, Maryland, United States

Oakland Medical Research Center

Troy, Michigan, United States

The Alliance for Multispecialty Research, LLC

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Heartland Clinical Research, Inc

Omaha, Nebraska, United States

Synexus Clinical Research US, Inc. - Site 1

Henderson, Nevada, United States

Synexus Clinical Research US, Inc. - Site 2

Henderson, Nevada, United States

Sierra Clinical Research - ClinEdge - PPDS

Las Vegas, Nevada, United States

Office - Site 1

Las Vegas, Nevada, United States

Office - Site 2

Las Vegas, Nevada, United States

Advanced Research Institute

Reno, Nevada, United States

Drug Trials America - ClinEdge

Hartsdale, New York, United States

Carolinas Research Center

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Medication Management LLC

Greensboro, North Carolina, United States

Carolina Research

Greenville, North Carolina, United States

Peters Medical Research, LLC - ClinEdge - PPDS

High Point, North Carolina, United States

Dayton Gastroenterology, Inc

Dayton, Ohio, United States

Prestige Clinical Research

Franklin, Ohio, United States

Central Sooner Research

Norman, Oklahoma, United States

Synexus Clinical Research US, Inc. - Anderson

Anderson, South Carolina, United States

Clinical Trials of South Carolina

Charleston, South Carolina, United States

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Rapid City Medical Center LLP

Rapid City, South Dakota, United States

Multi Specialty Clinical Research

Johnson City, Tennessee, United States

Clinical Research Associates Inc

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, 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

Ben Taub General Hospital

Houston, Texas, United States

Precision Research Institute, LLC

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

Rio Grande Gastroenterology

McAllen, Texas, United States

Digestive System Healthcare

Pasadena, Texas, United States

Pearland Physicians

Pearland, Texas, United States

Synexus Clinical Research US, Inc. - Plano

Plano, Texas, United States

Quality Research Inc

San Antonio, Texas, United States

Gastroenterology Research of San Antonio (GERSA)

San Antonio, Texas, 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 Clinical Research US, Inc. - Layton

Layton, Utah, United States

Advanced Research Institute

Ogden, Utah, United States

University of Utah Hospital- Health Sciences Center - PPDS

Salt Lake City, Utah, United States

New River Valley Research Institute

Christiansburg, Virginia, United States

Verity Research, Inc.

Fairfax, Virginia, United States

Blue Ridge Medical Research

Lynchburg, Virginia, United States

Washington Gastroenterology

Bellevue, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Multiprofile Hospital for Active Treatment Puls AD - PPDS

Blagoevgrad, , Bulgaria

University Multiprofile Hospital for Active Treatment

Pleven, , Bulgaria

Second Multiprofile Hospital for Active Treatment Sofia

Sofia, , Bulgaria

Medical Center Excelsior OOD - PPDS

Sofia, , Bulgaria

Diagnostic and Consulting Center Aleksandrovska EOOD

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

PreventaMed s.r.o.

Olomouc, , Czechia

Synexus Czech s.r.o.

Prague, , Czechia

MEDIC KRAL s.r.o.

Prague, , Czechia

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z. Oddeleni gastroenterolgie

Ústí nad Labem, , Czechia

Nemocnice Pardubickeho kraje, a.s. Orlickoustecka nemocnice, Interni oddeleni

Ústí nad Orlicí, , Czechia

Synexus (DRS) - Synexus Magyarország Kft. Budapest

Budapest, , Hungary

Synexus Affiliate - Synexus Magyarorszag Kft. Debrecen

Debrecen, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Synexus (DRS) - Synexus Magyarorszag Kft. Gyula

Gyula, , Hungary

Synexus Affiliate BKS Research Kft. Hatvan

Hatvan, , Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Synexus (DRS) - Synexus Magyarország Kft. Zalaegerszeg

Zalaegerszeg, , Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Bydgoszcz, , Poland

Gabinet Lekarski-Janusz Rudzinski

Bydgoszcz, , Poland

Synexus - Czestochowa

Częstochowa, , Poland

Synexus - Gdansk

Gdansk, , Poland

Synexus - Gdynia

Gdynia, , Poland

Synexus - Katowice

Katowice, , Poland

Synexus Affiliate - Krakowskie Centrum Medyczne

Krakow, , Poland

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

Ksawerów, , Poland

Synexus - Lodz

Lodz, , Poland

Santa Familia Centrum Badań Profilaktyki i Leczenia

Lodz, , Poland

Synexus - Poznan

Poznan, , Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, , Poland

Twoja Przychodnia - Szczecińskie Centrum Medyczne

Szczecin, , Poland

Gastromed Specjalistyczne Centrum Gastrologii i Endoskopii

Torun, , Poland

Synexus - Warsaw

Warsaw, , Poland

Synexus - Wroclaw

Wroclaw, , Poland

Melita Medical

Wroclaw, , Poland

Synexus - Wales Clinical Research Centre

Cardiff, , United Kingdom

Synexus - Lancashire Clinical Research Centre

Chorley, , United Kingdom

Synexus - Midlands Clinical Research Centre

Edgbaston, , United Kingdom

CPS Research

Glasgow, , United Kingdom

Synexus - Hexham Clinical Research Centre

Hexham, , United Kingdom

Synexus - Merseyside Clinical Research Centre

Liverpool, , United Kingdom

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

Countries

United States; Bulgaria; Czechia; Hungary; Poland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36191284 (View on PubMed)

Chey 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.

Reference Type: DERIVED

PMID: 35679950 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-002668-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HP-301

Identifier Type: -

Identifier Source: org_study_id