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Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
dexlansoprazole based triple therapy
rabeprazole-based triple therapy
Sponsored by
Kaohsiung Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring dexlansoprazole MR, rabeprazole, Helicobacter pylori, triple therapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or non-pregnant female aged more than 20 years.
  2. H. pylori-infected outpatients
  3. Mental and legal ability to give a written informed consent.

Exclusion Criteria:

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

Sites / Locations

  • Kaohsiung Medical University Hospital
  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

dexlansoprazole based triple therapy

rabeprazole-based triple therapy

Arm Description

dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

rabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

Outcomes

Primary Outcome Measures

The rate of H.pylori eradication
Evaluate eradication outcome by 13C urea breath test

Secondary Outcome Measures

Drug Compliance
Good drug compliance measured by number of subjects taking >= 80% eradication medicines

Full Information

First Posted
August 27, 2015
Last Updated
September 1, 2015
Sponsor
Kaohsiung Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02541786
Brief Title
Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
Official Title
Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. It is effective for symptom control of patients with gastroesophageal reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H.pylori infection.
Detailed Description
Helicobacter pylori (H.pylori) infect more than 50% of humans globally. It is the major cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (MALToma). H.pylori eradication has become the standard and most widely adopted therapy to cure peptic ulcer disease. This therapy is also strongly recommended in the treatment of H pylori-related MALToma. In regions with high incidence of gastric adenocarcinoma, eradication of H pylori is advocated as a preventative measure. Proton pump inhibitor (PPI) is one of the key medicines in anti-H pylori regimens. It possesses anti-H pylori activity, and, by reducing gastric acid secretion, it also increases bioavailability and activity of some antibiotics. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H pylori infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
dexlansoprazole MR, rabeprazole, Helicobacter pylori, triple therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexlansoprazole based triple therapy
Arm Type
Active Comparator
Arm Description
dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Arm Title
rabeprazole-based triple therapy
Arm Type
Experimental
Arm Description
rabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
dexlansoprazole based triple therapy
Other Intervention Name(s)
Dexilant-based triple therapy
Intervention Description
dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
rabeprazole-based triple therapy
Other Intervention Name(s)
Pariet-based triple therapy
Intervention Description
rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days
Primary Outcome Measure Information:
Title
The rate of H.pylori eradication
Description
Evaluate eradication outcome by 13C urea breath test
Time Frame
6 weeks after finishing study drugs
Secondary Outcome Measure Information:
Title
Drug Compliance
Description
Good drug compliance measured by number of subjects taking >= 80% eradication medicines
Time Frame
6 weeks after finishing study drugs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant female aged more than 20 years. H. pylori-infected outpatients Mental and legal ability to give a written informed consent. 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
DENG-CHYANG WU, MD, PHD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection

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