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Sponsored by: |
Korea Otsuka Pharmaceutical Co.,Ltd. |
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Information provided by: | Korea Otsuka Pharmaceutical Co.,Ltd. |
ClinicalTrials.gov Identifier: | NCT00576706 |
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 III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 396 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Rebamipide
Rebamipide 100㎎, 12 weeks
|
2: Active Comparator |
Drug: Misoprostol
Misoprostol 200㎍ 12 weeks
|
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Geumbo Lee | 822-3465-5496 | gb122@otsuka.co.kr |
Korea, Republic of | |
Recruiting | |
Daegu, Korea, Republic of | |
Recruiting | |
Seoul, Korea, Republic of | |
Recruiting | |
Suwon, Korea, Republic of | |
Recruiting | |
Chonju, Korea, Republic of | |
Recruiting | |
Pusan, Korea, Republic of | |
Recruiting | |
Gwangju, Korea, Republic of | |
Recruiting | |
Daejeon, Korea, Republic of |
Principal Investigator: | Soo-Heon Park, MD PhD | Catholic University Hospital |
Responsible Party: | Korea Otsuka Pharmaceutical Co.,Ltd. ( Korea Otsuka Pharmaceutical Co.,Ltd. ) |
Study ID Numbers: | 037-KOA-0701i |
Study First Received: | December 17, 2007 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00576706 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy |
Anti-Inflammatory Agents Antioxidants Osteoarthritis Arthritis, Rheumatoid Bone Diseases Rebamipide Musculoskeletal Diseases Arthritis Connective Tissue Diseases Spondylitis, Ankylosing Anti-Inflammatory Agents, Non-Steroidal Analgesics Spondylarthritis |
Spondylitis Spondylarthropathies Ankylosis Spinal Diseases Autoimmune Diseases Joint Diseases Spondylarthropathy Misoprostol Rheumatic Diseases Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Antioxidants Molecular Mechanisms of Pharmacological Action Oxytocics Osteoarthritis Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Infection Bone Diseases Rebamipide Musculoskeletal Diseases Sensory System Agents Therapeutic Uses Arthritis |
Abortifacient Agents Anti-Ulcer Agents Connective Tissue Diseases Spondylitis, Ankylosing Anti-Inflammatory Agents, Non-Steroidal Analgesics Spondylarthritis Spondylitis Spondylarthropathies Ankylosis Spinal Diseases Autoimmune Diseases Immune System Diseases Joint Diseases Misoprostol |