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Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 17, 2008
Last updated: April 2, 2008
Last verified: March 2008
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

Condition Intervention Phase
Osteoarthritis, Knee
Drug: Celecoxib
Drug: 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:
  • Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Patient's and Physician's Global Assessment of Pain [ 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 ]
  • Patient's Assessment of Arthritis Pain according to VAS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]

Enrollment: 380
Study Start Date: December 2003
Study Completion Date: September 2004
Arms Assigned Interventions
Experimental: A Drug: Celecoxib
200 mg oral capsule once daily for 6 weeks
Placebo Comparator: B Drug: Placebo
Matched oral placebo for 6 weeks


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • OA of the knee in flare state at baseline visit and functional capacity class of I-III
  • 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:

  • 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 baseline visit
  • Use of 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
  • Recieved corticosteroids or hyaluronic acid within certain timeframe before study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00640627

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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: NCT00640627     History of Changes
Other Study ID Numbers: A3191069 
Study First Received: March 17, 2008
Last Updated: April 2, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Cyclooxygenase 2 Inhibitors processed this record on October 20, 2016