NSAIDs-induced Small-intestinal InjuriesNCT00862628
The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries
A study testing Rebamipide in people with NSAIDs-induced Small-intestinal Injuries, run by Nagoya University at 2 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- NSAIDs-induced Small-intestinal Injuries
- What is being tested?
- Rebamipide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesJapan
- Study dates
- Oct 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- 20 to 85 years of age
- RA, OA, or low back pain
- No change of drugs before 3 months
- Under 5 mg of corticosteroid use
- CRP < 1mg/dl
- Small-intestinal mucosal injuries more than one
- Hemoglobin level is below normal range
Who cannot join
- Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
- Prostaglandins, metronidazole or salazosulfapyridine
- Can not swallow
- Eith pacemaker
- After gastrointestinal operation
- Serious concomitant cardiovascular, endocrine, gastrointestinal(including symptoms of ileus), neurologic, psychiatric, renal, or respiratory disease.
- Taking rebamipide before one week
- Any other conditions that the investigator feels would interfere with data interpretation or create under risk.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Department of Gastroenterology, Nagoya University Graduate School of Medicine
Nagoya, Aichi-ken, 466-8550
Naoki Ohmiya, M.D., Ph.D., 81-52-744-2172, nohmiya@med.nagoya-u.ac.jp
Naoki Ohmia, M.D., Ph.D
Department of Gastroenterology, Nagoya University Graduate School of Medicine
Nagoya, Aichi-ken, 466-8550
Naoki Ohmiya, M.D., Ph.D., 81-52-744-2172, nohmiya@med.nagoya-u.ac.jp
About this study
The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.
- Conditions
- NSAIDs-induced Small-intestinal Injuries
- Being tested
- Rebamipide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
100mg tid, 4 or 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Rebamipide | Experimental | Not described Receives: Drug: Rebamipide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of mucosal breaks
Measured: 4 and 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSAIDs-induced Small-intestinal InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Investigators
- Naoki Ohmiya, M.D., Ph.D., Principal investigator, Nagoya University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862628
- Sponsor's protocol ID
- NO-003
- Status last verified
- Sep 2009
- First submitted
- 16 Mar 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries
- ClinicalTrials.gov ID
- NCT00862628
- Acronym / sponsor ID
- NO-003
- Conditions
- NSAIDs-induced Small-intestinal Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 17 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rebamipide | Experimental | Drug: Rebamipide |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- 20 to 85 years of age
- RA, OA, or low back pain
- No change of drugs before 3 months
- Under 5 mg of corticosteroid use
Key exclusion criteria (8 listed)
- Known or suspected small-bowel disease, including Crohn's disease and seronegative arthritis
- Prostaglandins, metronidazole or salazosulfapyridine
- Can not swallow
- Eith pacemaker
- After gastrointestinal operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebamipide100mg tid, 4 or 8 weeks | Drug | Rebamipide |
Primary outcome
The number of mucosal breaks
Time frame: 4 and 8 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoki Ohmiya, M.D., Ph.D. principal investigator
Nagoya University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebamipide in people with NSAIDs-induced Small-intestinal Injuries, run by Nagoya University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naoki Ohmiya, MD., Ph.D. (81-52-744-2172, nohmiya@med.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of mucosal breaks (time frame: 4 and 8 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2009; AzTrials last refreshed its copy on 8 Nov 2026.