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.
Information provided by:
Pfizer Identifier:
First received: March 12, 2008
Last updated: March 12, 2009
Last verified: March 2009
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:

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


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00638807

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc 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, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 23, 2016