The Effect of Rebamipide for Non-Steroidal Anti-Inflammatory Drugs (NSAID) - Induced Small-Intestinal Injuries

This study is not yet open for participant recruitment.

Verified by Nagoya University, March 2009

First Received: March 16, 2009 No Changes Posted

Sponsored by:	Nagoya University
Information provided by:	Nagoya University
ClinicalTrials.gov Identifier:	NCT00862628

Purpose

The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.

Condition	Intervention
NSAIDs-Induced Small-Intestinal Injuries	Drug: Rebamipide

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Rebamipide

U.S. FDA Resources

Further study details as provided by Nagoya University:

Primary Outcome Measures:

The number of mucosal breaks [ Time Frame: 4 and 8 weeks after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	June 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rebamipide: Experimental	Drug: Rebamipide 100mg tid, 4 or 8 weeks

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862628

Contacts

Contact: Naoki Ohmiya, MD., Ph.D.

81-52-744-2172

nohmiya@med.nagoya-u.ac.jp

Locations

Japan, Aichi Prefecture
Department of Gastroenterology, Nagoya University Graduate School of Medicine
Nagoya, Aichi Prefecture, Japan, 466-8550
Department of Gastroenterology, Nagoya University Graduate School of Medicine
Nagoya, Aichi Prefecture, Japan, 466-8550

Sponsors and Collaborators

Nagoya University

Investigators

Principal Investigator:

Naoki Ohmiya, M.D., Ph.D.

Nagoya University Hospital

More Information

No publications provided

Responsible Party:	Nagoya University Graduate School of Medicine ( Department of Gastroenterology )
Study ID Numbers:	NO-003
Study First Received:	March 16, 2009
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00862628 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antioxidants
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Rebamipide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Protective Agents
Rebamipide
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2009