Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)

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: NCT00620867
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : November 6, 2008
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Brief Summary:
To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Ibuprofen Drug: celecoxib Other: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Efficacy and Tolerability of Once Daily Celebrex (Celecoxib) and Three Times Daily Ibuprofen vs. Placebo in the Treatment of Subjects With Osteoarthritis of the Knee
Study Start Date : October 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Ibuprofen Drug: Ibuprofen
800 mg oral tablet three time daily with meals for 6 weeks

Experimental: Celecoxib Drug: celecoxib
200 mg oral capsule once daily with morning meal for 6 weeks

Placebo Comparator: placebo Other: placebo
matched placebo orally for 6 weeks

Primary Outcome Measures :
  1. Change from baseline in patient's assessment of arthritis pain according to visual analogue scale (VAS) [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. Vital signs [ Time Frame: Weeks 2 and 6 ]
  2. Physical examination [ Time Frame: Week 6 ]
  3. Laboratory test results [ Time Frame: Week 6 ]
  4. Adverse events [ Time Frame: Weeks 2 and 6 ]
  5. Change from baseline in patient's and physician's global assessment of pain [ Time Frame: Weeks 2 and 6 ]
  6. Pain Satisfaction Scale [ Time Frame: Days 1-7 ]
  7. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ]
  8. Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ]
  9. Change from baseline in patient's assessment of arthritis pain according to VAS [ Time Frame: Week 2 ]

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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:

  • Aged >= 40 years old
  • Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
  • Functional capacity class of I-III

Exclusion Criteria:

  • Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
  • Acute joint trauma at index joint within the past 3 months with active symptoms
  • Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
  • Use of mobility assisting device for <6 weeks or use of walker

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): NCT00620867

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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: NCT00620867     History of Changes
Other Study ID Numbers: A3191063
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: November 6, 2008
Last Verified: November 2008

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