Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication

NCT02827942 | Completed Phase 3 DMC

• 1 other identifier: R15-006
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1 week. Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.

Conditions

Gastritis Associated With Helicobacter Pylori

Keywords

pylori

Outcome Measures

Primary Outcomes (1)

• The success or failure of eradication

  Success or failure of eradication of H. pylor is to be diagnosed at 4 to 8 weeks after the end of the eradication therapy by13C-urea breath test.

  4 to 8 weeks after the end of the eradication therapy

Secondary Outcomes (1)

• Adverse events

  1 week

Study Arms (2)

Dual therapy

EXPERIMENTAL

Patients assigned to this group are treated with dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week. The eradication rate attained with this regimen is measured.

Drug: vonoprazan 20 mg bid; Drug: Amoxicillin 500 mg tid

Triple therapy

ACTIVE COMPARATOR

Patients assigned to this group are treated with the triple therapy with vonoprazan 20 mg bid, clarithromycin 200 mg bid and amoxicillin 750 mg bid for 1 week as the first line therapy or the triple therapy with vonoprazan 20 mg bid, metronidazole 250 mg bid and amoxicillin 750 mg bid for 1 week as the second line therapy. The eradication rates attained with these regimens are measured.

Drug: vonoprazan 20 mg bid; Drug: Amoxicillin 750 mg bid; Drug: Clarithromycin 200 mg bid; Drug: Metronidazole 250 mg bid

Interventions

vonoprazan 20 mg bid DRUG

Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.

Also known as: takecab® 20 mg bid

Dual therapy; Triple therapy

Amoxicillin 500 mg tid DRUG

Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. Then, 500 mg of amoxicillin is dosed three times daily for 1 week.

Also known as: Sawacillin® 500 mg tid

Dual therapy

Amoxicillin 750 mg bid DRUG

Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. However, the standard regimen in Japan, 750 mg of amoxicillin is dosed twice daily with clarithromycin or metronidazole for 1 week. Then, 750 mg of amoxicillin is dosed twice daily.

Also known as: Sawacillin® 750 mg bid

Triple therapy

Clarithromycin 200 mg bid DRUG

Clarithromycin is antibiotics. It is involved in the standard first line regimen in Japan. Then, 200 mg of clarithromycin is dosed twice daily for 1 week.

Also known as: Claris® 200 mg bid

Triple therapy

Metronidazole 250 mg bid DRUG

Metronidazole is antimicrobial agent. It is involved in the standard second line regimen in Japan. Then, 250 mg of metronidazole is dosed twice daily for 1 week.

Also known as: fragile 250 mg bid

Triple therapy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients infected with H. pylori
• Patients who are not allergic to any of drugs used in this study
• Patients who agree to participate to the study patients who are treatment naive for eradication of H. pylori

You may not qualify if:

• Patients not infected with H. pylori
• Patients who are allergic to any of drugs used in this study
• Patients who do not agree to participate to the study
• Severe general condition, such as renal insufficiency or liver dysfunction
• History of gastrectomy
• Inability to undergo eradication therapy
• Patients who have ever undergone the eradication therapy for H. pylori infection

Sponsors & Collaborators

• Hamamatsu University: lead

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Location

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; BID protein, human; Amoxicillin; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Takahisa Furuta, MD, PhD

  Hamamatsu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Comparison of the dual VPZ/AMPC therapy and triple VPZ/AMPC/CAM therapy

Study Record Dates

• First Submitted: June 12, 2016
• First Posted: July 11, 2016
• Study Start: July 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)