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PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity (PRESENT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576706
First Posted: December 19, 2007
Last Update Posted: November 16, 2011
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.
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.
December 17, 2007
December 19, 2007
November 16, 2011
December 2007
March 2010   (Final data collection date for primary outcome measure)
Incidence rate of gastric ulcer on gastroendoscopy result at 12-week [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT00576706 on ClinicalTrials.gov Archive Site
  • Rate of Therapeutic failure [ Time Frame: 12 weeks ]
  • Severity of gastrointestinal symptoms [ Time Frame: 12 weeks ]
  • Antacid consumption [ Time Frame: 12 weeks ]
  • Rate of Therapeutic failure [ Time Frame: 12 weeks ]
  • Degree and occurrence frequency of gastrointestinal symptoms [ Time Frame: 12 weeks ]
  • Antacid consumption [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity
A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications
To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Ankylosing Spondylitis
  • Drug: Rebamipide
    Rebamipide 100㎎, 12 weeks
    Other Name: Mucosta
  • Drug: Misoprostol
    Misoprostol 200㎍ 12 weeks
    Other Name: Cytotec®
  • Experimental: 1
    Intervention: Drug: Rebamipide
  • Active Comparator: 2
    Intervention: Drug: Misoprostol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
396
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Signed written informed consent after being informed of the clinical trial
  2. Males or females 19 years of age
  3. Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.

Exclusion Criteria:

  1. Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
  2. Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00576706
037-KOA-0701i
Not Provided
Not Provided
Not Provided
Korea Otsuka Pharmaceutical Co.,Ltd.
Korea Otsuka Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Soo-Heon Park, MD PhD Catholic University Hospital
Korea Otsuka Pharmaceutical Co., Ltd.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP