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

NCT00640627

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85051, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Knee
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Osteoarthritis, KneeEfficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen
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  2. Tucson, Arizona
  3. Long Beach, California
  4. Paramount, California
  5. Tustin, California
  6. Colorado Springs, Colorado
  7. Wheat Ridge, Colorado
  8. DeLand, Florida
  9. Naples, Florida
  10. Pembroke Pines, Florida
  11. Saint Petersburg, Florida
  12. Woodstock, Georgia
  13. Overland Park, Kansas
  14. New Orleans, Louisiana
  15. Baltimore, Maryland
  16. Flowood, Mississippi
  17. Chesterfield, Missouri
  18. Reno, Nevada
  19. Albuquerque, New Mexico
  20. Mason, Ohio
  21. Beaver, Pennsylvania
  22. Camp Hill, Pennsylvania
  23. Jenkintown, Pennsylvania
  24. Greensboro, South Carolina
  25. Johnson City, Tennessee
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  27. Nashville, Tennessee
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Osteoarthritis, KneeSafety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen
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  2. Buena Park, California
  3. Denver, Colorado
  4. Washington, District of Columbia
  5. Longwood, Florida
  6. Miami, Florida
  7. Zephyrhills, Florida
  8. Boise, Idaho
  9. Boise, Idaho
  10. Morton Grove, Illinois
  11. Wichita, Kansas
  12. Wichita, Kansas
  13. Wheaton, Maryland
  14. Springfield, Missouri
  15. Bozeman, Montana
  16. Trenton, New Jersey
  17. Binghamton, New York
  18. Brooklyn, New York
  19. New York, New York
  20. Cary, North Carolina
  21. Winston-Salem, North Carolina
  22. Bismarck, North Dakota
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  24. Portland, Oregon
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  26. Johnstown, Pennsylvania
  27. Warwick, Rhode Island
  28. Charleston, South Carolina
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  31. Arlington, Virginia
  32. Norfolk, Virginia
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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Celecoxib Versus Placebo in the Treatment of Patients With Osteoarthritis of the Knee Who Were Unresponsive to Naproxen and Ibuprofen
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: Celecoxib
    200 mg oral capsule once daily for 6 weeks
  • Drug: Placebo
    Matched oral placebo for 6 weeks
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2008)
380
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00640627
Other Study ID Numbers  ICMJE A3191069
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP