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

NSAIDs-induced Small-intestinal Injuries Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00862628
• Other study ID #: NO-003
• Status: Not yet recruiting
• Phase: N/A
• First received: March 16, 2009
• Last updated: September 18, 2009
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: September 2009
• Source: Nagoya University
• Contact: Naoki Ohmiya, MD., Ph.D.
• Phone: 81-52-744-2172
• Email: nohmiya[@]med.nagoya-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSAIDs-induced Small-intestinal Injuries

Intervention

Drug:
• Rebamipide
100mg tid, 4 or 8 weeks

Locations

Country	Name	City	State
Japan	Department of Gastroenterology, Nagoya University Graduate School of Medicine	Nagoya	Aichi Prefecture
Japan	Department of Gastroenterology, Nagoya University Graduate School of Medicine	Nagoya	Aichi Prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Nagoya University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of mucosal breaks		4 and 8 weeks after treatment	Yes