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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862628
Recruitment Status : Unknown
Verified September 2009 by Nagoya University.
Recruitment status was:  Not yet recruiting
First Posted : March 17, 2009
Last Update Posted : September 21, 2009
Sponsor:
Information provided by:
Nagoya University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : October 2010

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




Primary Outcome Measures :
  1. The number of mucosal breaks [ Time Frame: 4 and 8 weeks after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862628


Contacts
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Contact: Naoki Ohmiya, MD., Ph.D. 81-52-744-2172 nohmiya@med.nagoya-u.ac.jp

Locations
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Japan
Department of Gastroenterology, Nagoya University Graduate School of Medicine
Nagoya, Aichi Prefecture, Japan, 466-8550
Contact: Naoki Ohmiya, M.D., Ph.D.    81-52-744-2172    nohmiya@med.nagoya-u.ac.jp   
Principal Investigator: Naoki Ohmia, M.D., Ph.D         
Department of Gastroenterology, Nagoya University Graduate School of Medicine
Nagoya, Aichi Prefecture, Japan, 466-8550
Contact: Naoki Ohmiya, M.D., Ph.D.    81-52-744-2172    nohmiya@med.nagoya-u.ac.jp   
Sponsors and Collaborators
Nagoya University
Investigators
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Principal Investigator: Naoki Ohmiya, M.D., Ph.D. Nagoya University Hospital
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Responsible Party: Department of Gastroenterology, Nagoya University Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00862628    
Other Study ID Numbers: NO-003
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Wounds and Injuries
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors