The effect of rebamipide for healthy subjects with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)-induced small-intestinal injury: a prospective, randomised, double-blinded, placebo-controlled study
Completed
- Conditions
- on-Steroidal Anti-Inflammatory Drug (NSAID)-induced small-intestinal injuryDigestive SystemSmall-intestinal injury
- Registration Number
- ISRCTN50390099
- Lead Sponsor
- Individual Sponsor (Japan)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 72
Inclusion Criteria
1. Male sex
2. Aged at least 20 years
3. Body Mass Index (BMI) 18.5 - 25 kg/m^2
4. Lack of history of GastroIntestinal (GI) disorder
5. Japanese population
6. Healthy on examination by a physician
7. Subject able to comprehend and give informed consent for participation in this study
8. Signed informed consent form
Exclusion Criteria
1. Active gastrointestinal disease
2. Use of ulcerogenic medications within two weeks before starting the study
3. Prior gastric or intestinal surgery
4. Pregnancy
5. Physician objection
6. Concurrent participation in any other clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the preventive effect of rebamipide for NSAIDs-induced small-intestinal mucosal brakes, evaluated by capsule endoscopy at time-course of day 0 and day 14.
- Secondary Outcome Measures
Name Time Method To evaluate the preventive effect of rebamipide for NSAIDs-induced small-intestinal slight injuries, such as erythema and petechiae, evaluated by capsule endoscopy at time-course of day 0 and day 14.