PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Last updated: November 15, 2011
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Musculoskeletal Diseases

Osteoarthritis

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT00576706
037-KOA-0701i
  • Ages > 19
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 theprevious 4 weeks.

Exclusion

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

Study Design

Total Participants: 396
Study Start date:
December 01, 2007
Estimated Completion Date:
March 31, 2010

Connect with a study center

  • Bucheon,
    Korea, Republic of

    Site Not Available

  • Chonju,
    Korea, Republic of

    Site Not Available

  • Daegu,
    Korea, Republic of

    Site Not Available

  • Daejeon,
    Korea, Republic of

    Site Not Available

  • Gwangju,
    Korea, Republic of

    Site Not Available

  • Incheon,
    Korea, Republic of

    Site Not Available

  • Jinju,
    Korea, Republic of

    Site Not Available

  • Pusan,
    Korea, Republic of

    Site Not Available

  • Seoul,
    Korea, Republic of

    Site Not Available

  • Suwon,
    Korea, Republic of

    Site Not Available

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