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

September 18, 2009 updated by: Nagoya University
The purpose of this study is to evaluate the efficacy of rebamipide for NSAID-induced small-intestinal injuries.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rebamipide
Drug: Rebamipide
100mg tid, 4 or 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of mucosal breaks
Time Frame: 4 and 8 weeks after treatment
4 and 8 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nagoya University

Investigators

  • Principal Investigator: Naoki Ohmiya, M.D., Ph.D., Nagoya University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2010

Study Completion (ANTICIPATED)

October 1, 2010

Study Registration Dates

First Submitted

March 16, 2009

First Submitted That Met QC Criteria

March 16, 2009

First Posted (ESTIMATE)

March 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2009

Last Update Submitted That Met QC Criteria

September 18, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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