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

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. Identifier: NCT00576706
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : November 16, 2011
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoarthritis Ankylosing Spondylitis Drug: Rebamipide Drug: Misoprostol Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : December 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: 1 Drug: Rebamipide
Rebamipide 100㎎, 12 weeks
Other Name: Mucosta

Active Comparator: 2 Drug: Misoprostol
Misoprostol 200㎍ 12 weeks
Other Name: Cytotec®

Primary Outcome Measures :
  1. Incidence rate of gastric ulcer on gastroendoscopy result at 12-week [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Rate of Therapeutic failure [ Time Frame: 12 weeks ]
  2. Severity of gastrointestinal symptoms [ Time Frame: 12 weeks ]
  3. Antacid consumption [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00576706

Korea, Republic of
Bucheon, Korea, Republic of
Chonju, Korea, Republic of
Daegu, Korea, Republic of
Daejeon, Korea, Republic of
Gwangju, Korea, Republic of
Incheon, Korea, Republic of
Jinju, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Suwon, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
Principal Investigator: Soo-Heon Park, MD PhD Catholic University Hospital

Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd. Identifier: NCT00576706     History of Changes
Other Study ID Numbers: 037-KOA-0701i
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.:
Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents