Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00638807
First received: March 12, 2008
Last updated: March 12, 2009
Last verified: March 2009
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Purpose
To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis, Knee |
Drug: Celecoxib Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Placebo Controlled Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee Non-Responsive to Naproxen and Ibuprofen |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoarthritis
Drug Information available for:
Ibuprofen
Naproxen
Naproxen sodium
Ibuprofen sodium
Ibuprofen lysinate
Celecoxib
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient's Assessment of Arthritis Pain, according to VAS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
- The Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- Patient's and Physician's Global Assessment of Arthritis [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]
- The Medical Outcomes Study Sleep Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Weeks 0-6 ] [ Designated as safety issue: Yes ]
- Laboratory tests [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
- Vital signs [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
- Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
- Serious adverse events [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]
| Enrollment: | 388 |
| Study Start Date: | December 2003 |
| Study Completion Date: | July 2004 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Celecoxib
200 mg oral capsule once daily with morning meal for 6 weeks
|
| Placebo Comparator: B |
Other: Placebo
Matched oral placebo for 6 weeks
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Inclusion criteria:
- Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit
- Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability, or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability
Exclusion Criteria:
Exclusion criteria:
- Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
- Received acetaminophen within 24 hours of the baseline visit
- Use of a mobility assisting device for less than six weeks prior to study screening or use of a walker
- History of gastrointestinal (GI) perforation, obstruction, or bleeding
- Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
- Received corticosteroids or hyaluronic acid within certain timeframe before study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638807
Show 33 Study Locations
Show 33 Study LocationsSponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc |
| ClinicalTrials.gov Identifier: | NCT00638807 History of Changes |
| Other Study ID Numbers: | A3191082 |
| Study First Received: | March 12, 2008 |
| Last Updated: | March 12, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Naproxen Ibuprofen Celecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013