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Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer

Primary Purpose

Stomach Ulcer

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Rebamipide
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Ulcer

Eligibility Criteria

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

Inclusion Criteria: Patients aged 20 years or older at time of consent H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification), • Solitary, • Longitudinal diameter: ->5 mm Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy Exclusion Criteria: Patients who have previously received H. pylori eradication therapy Patients with acute gastric ulcer Patients with linear ulcer Patients with complication of duodenal ulcer (excluding cicatrix) Patients who have undergone upper-GI tract or vagal nerve resection Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites) Patients with a history of amoxicillin shock Patients with infectious mononucleosis Patients with severe renal disorders Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Sites / Locations

  • Otsuka Pharmaceutical Co., Ltd.

Outcomes

Primary Outcome Measures

Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
The percentage of subjects in the analysis set in whom endoscopic assessment of gastric ulcer stage (Sakita-Miwa Classification: A1, A2, H1, H2, S1, or S2) at 8 weeks after trial treatment (H. pylori eradication therapy + IMP) was judged as healed (S1 or S2) was calculated and evaluated by group.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2005
Last Updated
May 11, 2021
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00233389
Brief Title
Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer
Official Title
A Post-marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2004 (Actual)
Primary Completion Date
September 1, 2005 (Actual)
Study Completion Date
September 9, 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Ulcer

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rebamipide
Primary Outcome Measure Information:
Title
Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
Description
The percentage of subjects in the analysis set in whom endoscopic assessment of gastric ulcer stage (Sakita-Miwa Classification: A1, A2, H1, H2, S1, or S2) at 8 weeks after trial treatment (H. pylori eradication therapy + IMP) was judged as healed (S1 or S2) was calculated and evaluated by group.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 20 years or older at time of consent H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification), • Solitary, • Longitudinal diameter: ->5 mm Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy Exclusion Criteria: Patients who have previously received H. pylori eradication therapy Patients with acute gastric ulcer Patients with linear ulcer Patients with complication of duodenal ulcer (excluding cicatrix) Patients who have undergone upper-GI tract or vagal nerve resection Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites) Patients with a history of amoxicillin shock Patients with infectious mononucleosis Patients with severe renal disorders Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katsuhisa Saito
Organizational Affiliation
Division of New Product Evaluation and Development
Official's Role
Study Director
Facility Information:
Facility Name
Otsuka Pharmaceutical Co., Ltd.
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer

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