Condition category
Digestive System
Date applied
11/07/2007
Date assigned
26/07/2007
Last edited
27/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Syunji Fujimori

ORCID ID

Contact details

2-9,Kanda Tukasa-cho Chiyoda-ku
Tokyo
101-8535
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

218044

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the prevention by rebamipide and placebo of Non-Steroidal Anti-Inflammatory Drug (NSAID)-induced small-intestinal injury in healthy subjects.

Ethics approval

This trial was approved by Nippon Medical School ethical committee on the 28th March 2007.

Study design

Double blind, randomised, placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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 names

Rebamipide

Primary outcome measures

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

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.

Overall trial start date

17/07/2007

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

72

Participant 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

Recruitment start date

17/07/2007

Recruitment end date

30/06/2008

Locations

Countries of recruitment

Japan

Trial participating centre

2-9,Kanda Tukasa-cho Chiyoda-ku
Tokyo
101-8535
Japan

Sponsor information

Organisation

Individual Sponsor (Japan)

Sponsor details

Dr Syunji Fujimori
2-9,Kanda Tukasa-cho Chiyoda-ku
Tokyo
101-8535
Japan

Sponsor type

Other

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Nippon Medical School (Japan) - covering the incidental costs of running this trial

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21270359

Publication citations

  1. Results

    Barnes MS, Horigan G, Cashman KD, Hill TR, Forsythe LK, Lucey AJ, McSorley EM, Kiely M, Bonham MP, Magee PJ, Strain JJ, Wallace JM, Maintenance of wintertime vitamin D status with cholecalciferol supplementation is not associated with alterations in serum cytokine concentrations among apparently healthy younger or older adults., J. Nutr., 2011, 141, 3, 476-481, doi: 10.3945/jn.110.131516.

Additional files

Editorial Notes