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

Primary Purpose

NSAIDs-induced Small-intestinal Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Rebamipide
Sponsored by
Nagoya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSAIDs-induced Small-intestinal Injuries

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Gastroenterology, Nagoya University Graduate School of Medicine
  • Department of Gastroenterology, Nagoya University Graduate School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rebamipide

Arm Description

Outcomes

Primary Outcome Measures

The number of mucosal breaks

Secondary Outcome Measures

Full Information

First Posted
March 16, 2009
Last Updated
September 18, 2009
Sponsor
Nagoya University
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1. Study Identification

Unique Protocol Identification Number
NCT00862628
Brief Title
The Effect of Rebamipide for Non-steroidal Anti-inflammatory Drugs (NSAID) - Induced Small-intestinal Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Nagoya University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSAIDs-induced Small-intestinal Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rebamipide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rebamipide
Intervention Description
100mg tid, 4 or 8 weeks
Primary Outcome Measure Information:
Title
The number of mucosal breaks
Time Frame
4 and 8 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naoki Ohmiya, MD., Ph.D.
Phone
81-52-744-2172
Email
nohmiya@med.nagoya-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naoki Ohmiya, M.D., Ph.D.
Organizational Affiliation
Nagoya University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Nagoya University Graduate School of Medicine
City
Nagoya
State/Province
Aichi Prefecture
ZIP/Postal Code
466-8550
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoki Ohmiya, M.D., Ph.D.
Phone
81-52-744-2172
Email
nohmiya@med.nagoya-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Naoki Ohmia, M.D., Ph.D
Facility Name
Department of Gastroenterology, Nagoya University Graduate School of Medicine
City
Nagoya
State/Province
Aichi Prefecture
ZIP/Postal Code
466-8550
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoki Ohmiya, M.D., Ph.D.
Phone
81-52-744-2172
Email
nohmiya@med.nagoya-u.ac.jp

12. IPD Sharing Statement

Learn more about this trial

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

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