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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.
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Osteoarthritis Ankylosing Spondylitis Drug: Rebamipide Drug: Misoprostol Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Korea Otsuka Pharmaceutical Co., Ltd.:

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

Secondary Outcome Measures:
  • Rate of Therapeutic failure [ Time Frame: 12 weeks ]
  • Severity of gastrointestinal symptoms [ Time Frame: 12 weeks ]
  • Antacid consumption [ Time Frame: 12 weeks ]

Estimated Enrollment: 396
Study Start Date: December 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Rebamipide
Rebamipide 100㎎, 12 weeks
Other Name: Mucosta
Active Comparator: 2 Drug: Misoprostol
Misoprostol 200㎍ 12 weeks
Other Name: Cytotec®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT00576706


Locations
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.
Investigators
Principal Investigator: Soo-Heon Park, MD PhD Catholic University Hospital
  More Information

Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00576706     History of Changes
Other Study ID Numbers: 037-KOA-0701i
First Submitted: December 17, 2007
First Posted: December 19, 2007
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
Osteoarthritis
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Misoprostol
Rebamipide
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents