A Multicenter, Randomized, Parallel-Group, Active-Controlled Double-Blind Study Conducted Under In-House Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L- 01069957 42 mg Plus Low-Dose Aspirin, Celecoxib 400 mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone - 12-Week NO-Rofecoxib Plus Aspirin Endoscopy Study
- Conditions
- Osteoarthritis (OA) ICD: M19.9 MedDRA: 10031161Rheumatoid Arthritis (RA) ICD: M06.9 MedDRA: 10039037
- Registration Number
- EUCTR2004-000612-54-SE
- Lead Sponsor
- Merck Sharp & Dohme (Sweden) AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1360
Greater than or equal to 45 years of age, clinical diagnosis of OA or RA, prior history of therapuetic benefit from non-steroidal anti-inflammatory or COX-2 inhibitory medications, free of gastric and/or duodenal ulcers at the time of randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Gastric and/or duodenal ulcers at the time of randomization, positive occult blood on stool Hemoccult testing, erosive esophagitis =2 American College of Rheumatology (ACR) functional class IV, uncontrolled diabetes, uncontrolled hypertension, angina (unstable or at rest), congestive heart failure, confounding medical condition, significant findings on screening physical examination and/or laboratory results
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the comparative cumulative incidence of gastric and/or duodenal ulcers (3 = mm) following administration over 12 weeks of L-001069957 21 mg plus EC aspirin 100 mg once daily, L-001069957 42 mg plus EC aspirin 100 mg once daily, celecoxib 200 mg twice daily plus EC aspirin 100 mg once daily and EC aspirin 100 mg daily.;Secondary Objective: To assess the general safety and tolerability of L-001069957 21 mg plus EC aspirin 100 mg once daily and L-001069957 42 mg plus EC aspirin 100 mg once daily.;Primary end point(s): Development of gastric and/or duodenal ulcers
- Secondary Outcome Measures
Name Time Method