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

This study has been completed.
Sponsor:
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00576706
First received: December 17, 2007
Last updated: November 15, 2011
Last verified: November 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of Therapeutic failure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Severity of gastrointestinal symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Antacid consumption [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT00576706     History of Changes
Other Study ID Numbers: 037-KOA-0701i
Study First Received: December 17, 2007
Last Updated: November 15, 2011
Health Authority: Korea: Food and Drug Administration

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
Arthritis, Rheumatoid
Osteoarthritis
Spondylitis
Spondylitis, Ankylosing
Ankylosis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Misoprostol
Rebamipide
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Antioxidants
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014