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

Study Overview
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Brief Summary
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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

Official Title
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A Post-marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy

Conditions
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Stomach Ulcer

Intervention / Treatment
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* Drug: Rebamipide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rebamipide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 8 |