Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection (REHYTRI)

March 21, 2017 updated by: Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection - a Randomized Controlled Trial (REHYTRI Study)

Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection with less cost than standard triple therapy. Whether reverse hybrid therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in first-line treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this multicentre, single-blind, and randomized-controlled trial (REHYTRI study), the investigator recruited patients with H pylori infection. Using a computer-generated randomization sequence, the investigator randomly allocated patients to either 12-day reverse hybrid therapy (pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg, amoxicillin 1 g for another 5 days; with all drugs given twice daily) or a 12-day standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg, amoxicillin 1 g for 12 days; with all drugs given twice daily) at a 1:1 ratio. Our primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

  • previous H pylori-eradication therapy
  • ingestion of antibiotics or bismuth within the prior 4 weeks
  • patients with allergic history to the medications used
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reverse hybrid therapy
pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily
Drug: Reverse hybrid therapy
pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days
Other Names:
  • Amoxicillin
  • Clarithromycin
  • Metronidazole
  • Pantoprazole
Active Comparator: Standard triple therapy
pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
Drug: Standard triple therapy
pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
Other Names:
  • Amoxicillin
  • Clarithromycin
  • Pantoprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in Which H. Pylori Was Eradicated
Time Frame: at the 6th week after the end of anti- H. pylori therapy
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
at the 6th week after the end of anti- H. pylori therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Collaborators

Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

January 25, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KaohsiungVGH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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