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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 : February 21, 2021
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

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

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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 ]

Information from the National Library of Medicine

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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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United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85051
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92804
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Paramount, California, United States, 90723
Pfizer Investigational Site
San Diego, California, United States, 92108
United States, Florida
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Miami, Florida, United States, 33186
Pfizer Investigational Site
Naples, Florida, United States, 34102
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33024
Pfizer Investigational Site
Saint Petersburg, Florida, United States, 33710
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47712
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Pfizer Investigational Site
Edison, New Jersey, United States, 08817
Pfizer Investigational Site
South Plainfield, New Jersey, United States, 07080
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87109
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States, 11203
Pfizer Investigational Site
New York, New York, United States, 10022-1009
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
Pfizer Investigational Site
Columbus, Ohio, United States, 43124
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Pfizer Investigational Site
Altoona, Pennsylvania, United States, 16601
Pfizer Investigational Site
Jenkintown, Pennsylvania, United States, 19046
Pfizer Investigational Site
Newtown, Pennsylvania, United States, 18940
United States, Rhode Island
Pfizer Investigational Site
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29407
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
Pfizer Investigational Site
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States, 37601
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75235
United States, Utah
Pfizer Investigational Site
Layton, Utah, United States, 84041
United States, Virginia
Pfizer Investigational Site
Danville, Virginia, United States, 24541
Sponsors and Collaborators
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. Identifier: NCT00620867    
Other Study ID Numbers: A3191063
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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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