Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen
- Registration Number
- NCT00640627
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To compare the safety and efficacy of celecoxib versus placebo in the treatment of patients with knee osteoarthritis who were unresponsive to treatment with prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 380
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Placebo - A Celecoxib -
- Primary Outcome Measures
Name Time Method Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) Week 6
- Secondary Outcome Measures
Name Time Method Patient's and Physician's Global Assessment of Pain Weeks 2 and 6 Western Ontario and McMaster Universities Osteoarthritis Index Week 6 The Medical Outcomes Study Sleep Scale Week 6 Adverse events Weeks 0-6 Laboratory tests Week 6 Vital signs Week 6 Physical examination Week 6 Patient's Assessment of Arthritis Pain according to VAS Week 2 Serious adverse events Up to 30 days after last dose
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Seattle, Washington, United States