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

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Reverse hybrid therapy
Standard triple therapy
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Proton pump inhibitor, Eradication

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reverse hybrid therapy

Standard triple therapy

Arm Description

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

pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily

Outcomes

Primary Outcome Measures

Number of Participants in Which H. Pylori Was Eradicated
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

Secondary Outcome Measures

Full Information

First Posted
January 25, 2015
Last Updated
March 21, 2017
Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02359435
Brief Title
Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection
Acronym
REHYTRI
Official Title
Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection - a Randomized Controlled Trial (REHYTRI Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, Proton pump inhibitor, Eradication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
440 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reverse hybrid therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Standard triple therapy
Arm Type
Active Comparator
Arm Description
pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily
Intervention Type
Drug
Intervention Name(s)
Reverse hybrid therapy
Other Intervention Name(s)
Pantoprazole, Amoxicillin, Clarithromycin, Metronidazole
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Standard triple therapy
Other Intervention Name(s)
Pantoprazole, Amoxicillin, Clarithromycin
Intervention Description
pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
Primary Outcome Measure Information:
Title
Number of Participants in Which H. Pylori Was Eradicated
Description
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Time Frame
at the 6th week after the end of anti- H. pylori therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-I Hsu, Bachelor
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan

12. IPD Sharing Statement

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

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