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

NCT00620867

Last updated date
Study Location
Pfizer Investigational Site
Anniston, Alabama, 36207, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Knee Osteoarthritis
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

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


- 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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Knee OsteoarthritisA Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)
NCT00650624
  1. Funabashi, Chiba
  2. Sakura, Chiba
  3. Chikushi-gun, Fukuoka
  4. Iizuka, Fukuoka
  5. Kurume, Fukuoka
  6. Yame, Fukuoka
  7. Chitose, Hokkaido
  8. Sapporo, Hokkaido
  9. Kamakura, Kanagawa
  10. Yokohama, Kanagawa
  11. Isahaya, Nagasaki
  12. Hirakata, Osaka
  13. Kanzaki-gun, Saga
  14. Karatsu, Saga
  15. Ogi-gun, Saga
  16. Itabashi-ku, Tokyo
  17. Setagaya-ku, Tokyo
  18. Shinjuku-Ku, Tokyo
  19. Taito-ku, Tokyo
  20. Yoyogi Shibuya-ku, Tokyo
  21. Saga,
  22. Tokyo,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Knee OsteoarthritisEfficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)
NCT00630929
  1. Bad Muender,
  2. Beckum,
  3. Berlin,
  4. Berlin,
  5. Berlin,
  6. Berlin,
  7. Ostseebad Damp,
  8. Schwerin,
  9. Stade,
  10. Tostedt,
  11. Weener,
  12. Barcelona,
  13. Barcelona,
  14. Cadiz,
  15. Guadalajara,
  16. Madrid,
  17. Madrid,
  18. Madrid,
  19. Oviedo,
  20. Sevilla,
  21. Valencia,
  22. Chelmsly Wood, Birmingham
  23. Truro, Cornwall
  24. Chorley, Lancs
  25. Liverpool, Lancs
  26. Cannock, Mid Staffordshire
  27. Addlestone, Surrey
  28. Huddersfield,
  29. London,
  30. London,
  31. Manchester,
  32. Newcastle Upon Tyne,
  33. Wigan,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Knee OsteoarthritisA Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
NCT00981357
  1. Miami, Florida
  2. Miami, Florida
  3. Overland Park, Kansas
  4. Overland Park, Kansas
  5. San Antonio, Texas
  6. Sherbrooke, Quebec
  7. Goteborg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Knee OsteoarthritisSafety and Efficacy of Celecoxib Versus Naproxen in the 6-Month Treatment of Knee Osteoarthritis
NCT00643799
  1. Montgomery, Alabama
  2. Phoenix, Arizona
  3. Tempe, Arizona
  4. Buena Park, California
  5. Paramount, California
  6. Rancho Mirage, California
  7. San Diego, California
  8. San Diego, California
  9. Denver, Colorado
  10. Washington, District of Columbia
  11. Clearwater, Florida
  12. Deland, Florida
  13. Jacksonville, Florida
  14. Miami, Florida
  15. Ocala, Florida
  16. Orlando, Florida
  17. Pembroke Pines, Florida
  18. Tampa, Florida
  19. Zephyrhills, Florida
  20. Rockford, Illinois
  21. Wichita, Kansas
  22. Wichita, Kansas
  23. Lexington, Kentucky
  24. Lexington, Kentucky
  25. Covington, Louisiana
  26. Metairie, Louisiana
  27. Clinton, Maryland
  28. Greenbelt, Maryland
  29. Hagerstown, Maryland
  30. Wheaton, Maryland
  31. Milford, Massachusetts
  32. Lansing, Michigan
  33. Flowood, Mississippi
  34. Kansas City, Missouri
  35. Lincoln, Nebraska
  36. Lincoln, Nebraska
  37. New York, New York
  38. Beachwood, Ohio
  39. Columbus, Ohio
  40. Columbus, Ohio
  41. Columbus, Ohio
  42. Oklahoma City, Oklahoma
  43. Bethlehem, Pennsylvania
  44. Duncansville, Pennsylvania
  45. Media, Pennsylvania
  46. Warwick, Rhode Island
  47. Austin, Texas
  48. Dallas, Texas
  49. San Angelo, Texas
  50. Salt Lake City, Utah
  51. Salt Lake City, Utah
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)
Official Title  ICMJE 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
Brief Summary To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.
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: Ibuprofen
    800 mg oral tablet three time daily with meals for 6 weeks
  • Drug: celecoxib
    200 mg oral capsule once daily with morning meal for 6 weeks
  • Other: placebo
    matched placebo orally for 6 weeks
Study Arms  ICMJE
  • Experimental: Ibuprofen
    Intervention: Drug: Ibuprofen
  • Experimental: Celecoxib
    Intervention: Drug: celecoxib
  • Placebo Comparator: placebo
    Intervention: Other: 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: February 12, 2008)
393
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2003
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT00620867
Other Study ID Numbers  ICMJE A3191063
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 November 2008

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