Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer
- Conditions
- Gastric ulcer
- Registration Number
- JPRN-jRCT1080220035
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
The results of the trial suggest that H. pylori eradication therapy alone is not sufficiently effective for treating gastric ulcer and should ideally be followed by ulcer treatment, and that rebamipide is effective and safe for post-eradication treatment of gastric ulcer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 309
Patients who are H pylori positive and have active gastric ulcer, and aged 20 yeas or older at time of concent
1. Patients who have previously received H. pylori eradication therapy
2. Patients with acute gastric ulcer
3. Patients with linear ulcer
4. Patients with complication of duodenal ulcer (excluding cicatrix)
5. Patients who have undergone upper-GI tract or vagal nerve resection
6. Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis
7. Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites)
8. Patients with a history of amoxicillin shock
9. Patients with infectious mononucleosis
10. Patients with severe renal disorders
11. Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide
12. Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide
13. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study
14. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Efficacy/safety
- Secondary Outcome Measures
Name Time Method