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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00638807
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : March 13, 2009
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Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Celecoxib Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2003
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS) [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Patient's Assessment of Arthritis Pain, according to VAS [ Time Frame: Week 2 ]
  2. The Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ]
  3. Patient's and Physician's Global Assessment of Arthritis [ Time Frame: Weeks 2 and 6 ]
  4. The Medical Outcomes Study Sleep Scale [ Time Frame: Week 6 ]
  5. Adverse events [ Time Frame: Weeks 0-6 ]
  6. Laboratory tests [ Time Frame: Week 6 ]
  7. Vital signs [ Time Frame: Week 6 ]
  8. Physical examination [ Time Frame: Week 6 ]
  9. Serious adverse events [ Time Frame: Up to 30 days after last dose ]

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00638807

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00638807     History of Changes
Other Study ID Numbers: A3191082
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

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
Cyclooxygenase 2 Inhibitors
Gout Suppressants