- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00638807
Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen
January 29, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
388
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35235
- Pfizer Investigational Site
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California
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Buena Park, California, United States, 90620
- Pfizer Investigational Site
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Colorado
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Denver, Colorado, United States, 80204
- Pfizer Investigational Site
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District of Columbia
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Washington, District of Columbia, United States, 20006
- Pfizer Investigational Site
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Florida
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Longwood, Florida, United States, 32779
- Pfizer Investigational Site
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Miami, Florida, United States, 33186
- Pfizer Investigational Site
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Zephyrhills, Florida, United States, 33540
- Pfizer Investigational Site
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Idaho
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Boise, Idaho, United States, 83704
- Pfizer Investigational Site
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Boise, Idaho, United States, 83706
- Pfizer Investigational Site
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Illinois
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Morton Grove, Illinois, United States, 60053
- Pfizer Investigational Site
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Kansas
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Wichita, Kansas, United States, 67206
- Pfizer Investigational Site
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Wichita, Kansas, United States, 67214
- Pfizer Investigational Site
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Maryland
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Wheaton, Maryland, United States, 20902
- Pfizer Investigational Site
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Missouri
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Springfield, Missouri, United States, 65807
- Pfizer Investigational Site
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Montana
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Bozeman, Montana, United States, 59715
- Pfizer Investigational Site
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New Jersey
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Trenton, New Jersey, United States, 08611
- Pfizer Investigational Site
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New York
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Binghamton, New York, United States, 13901
- Pfizer Investigational Site
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Brooklyn, New York, United States, 11203
- Pfizer Investigational Site
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New York, New York, United States, 10022-1009
- Pfizer Investigational Site
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North Carolina
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Cary, North Carolina, United States, 27609
- Pfizer Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- Pfizer Investigational Site
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North Dakota
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Bismarck, North Dakota, United States, 58506
- Pfizer Investigational Site
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Oregon
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Eugene, Oregon, United States, 97401
- Pfizer Investigational Site
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Portland, Oregon, United States, 97239
- Pfizer Investigational Site
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635-0909
- Pfizer Investigational Site
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Johnstown, Pennsylvania, United States, 15904
- Pfizer Investigational Site
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Rhode Island
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Warwick, Rhode Island, United States, 02886
- Pfizer Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29407
- Pfizer Investigational Site
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Tennessee
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New Tazewell, Tennessee, United States, 37825
- Pfizer Investigational Site
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Texas
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San Antonio, Texas, United States, 78229
- Pfizer Investigational Site
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Virginia
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Arlington, Virginia, United States, 22203
- Pfizer Investigational Site
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Norfolk, Virginia, United States, 23502
- Pfizer Investigational Site
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Washington
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Seattle, Washington, United States, 98166
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
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200 mg oral capsule once daily with morning meal for 6 weeks
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Placebo Comparator: B
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Matched oral placebo for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change from baseline in Patient's Assessment of Arthritis Pain, according to visual analog scale (VAS)
Time Frame: Week 6
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Week 6
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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The Medical Outcomes Study Sleep Scale
Time Frame: Week 6
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Week 6
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Adverse events
Time Frame: Weeks 0-6
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Weeks 0-6
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Laboratory tests
Time Frame: Week 6
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Week 6
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Vital signs
Time Frame: Week 6
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Week 6
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Physical examination
Time Frame: Week 6
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Week 6
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Serious adverse events
Time Frame: Up to 30 days after last dose
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Up to 30 days after last dose
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Patient's Assessment of Arthritis Pain, according to VAS
Time Frame: Week 2
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Week 2
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The Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame: Week 6
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Week 6
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Patient's and Physician's Global Assessment of Arthritis
Time Frame: Weeks 2 and 6
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Weeks 2 and 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Study Completion (Actual)
July 1, 2004
Study Registration Dates
First Submitted
March 12, 2008
First Submitted That Met QC Criteria
March 12, 2008
First Posted (Estimate)
March 19, 2008
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 29, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- A3191082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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