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
| ISRCTN | ISRCTN50390099 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50390099 |
| Protocol serial number | 218044 |
| Sponsor | Individual Sponsor (Japan) |
| Funder | Nippon Medical School (Japan) - covering the incidental costs of running this trial |
- Submission date
- 11/07/2007
- Registration date
- 26/07/2007
- Last edited
- 27/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Syunji Fujimori
Scientific
Scientific
2-9,Kanda Tukasa-cho Chiyoda-ku
Tokyo
101-8535
Japan
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind, randomised, placebo-controlled study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To evaluate the prevention by rebamipide and placebo of Non-Steroidal Anti-Inflammatory Drug (NSAID)-induced small-intestinal injury in healthy subjects. |
| Ethics approval(s) | This trial was approved by Nippon Medical School ethical committee on the 28th March 2007. |
| Health condition(s) or problem(s) studied | Non-Steroidal Anti-Inflammatory Drug (NSAID)-induced small-intestinal injury |
| Intervention | Rebamipide group: rebamipide 300 mg, diclofenac 75 mg and omeprazole 20 mg every day, thrice daily (t.i.d.) for two weeks Placebo group: placebo, diclofenac 75 mg and omeprazole 20 mg every day, t.i.d. for two weeks The subjects will be assigned to either rebamipide group or placebo group prior to the study. All medications will be taken orally. Final evaluation was done by capsule endoscopy at two weeks. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rebamipide |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 72 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/07/2007 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Japan
Study participating centre
2-9,Kanda Tukasa-cho Chiyoda-ku
Tokyo
101-8535
Japan
101-8535
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No |
