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