The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries

• Sponsor: Nagoya University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00862628
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arm: 1
• Duration (Months): 12
• Patients Per Site: 30
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
NSAIDs-induced Small-intestinal Injuries	Drug: Rebamipide	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2009
• Anticipated Primary Completion Date: Jun 1, 2010
• Anticipated Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rebamipide	Drug: Rebamipide; 100mg tid, 4 or 8 weeks

Outcome Measures

Primary Outcome Measures

1. The number of mucosal breaks [4 and 8 weeks after treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Nagoya University Graduate School of Medicine	Nagoya	Aichi Prefecture	Japan	466-8550
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00862628
• Other Study ID Numbers: NO-003
• First Posted: Mar 17, 2009
• Last Update Posted: Sep 21, 2009
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Wounds and Injuries; Rebamipide

Study Results

No Results Posted as of Sep 21, 2009