A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

NCT01147458

Last updated date
Study Location
Pfizer Investigational Site
Peoria, Arizona, 85381, 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
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray

- Subjects must be willing and able to stop all current pain therapy for the duration of the study

- Subjects must be willing and able to complete a daily diary

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


- BMI of >39 kg/m2


- Known allergy or hypersensitivity to naproxen


- Any condition or medical history that might interfere with the subject's ability to
complete the study visits and assessments

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 OsteoarthritisWearable Sensors in Knee OA
NCT04243096
  1. Boston, Massachusetts
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Knee OsteoarthritisEfficacy of Celecoxib Vs Placebo to Prevent Pain in a Paced Walk
NCT00194090
  1. Cleveland, Ohio
ALL GENDERS
45 Years+
years
MULTIPLE SITES
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
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
Official Title  ICMJE A Phase 2 Randomized, Double-Blinded, Double-Dummy, Placebo And Active Controlled Two Cohort Two-Way Cross-Over, Multi-Centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A 5-Lipoxygenase (5-Lox) Inhibitor PF-04191834 Alone And In Combination With Naproxen In Patients With Flare-Enriched Osteoarthritis Of The Knee
Brief Summary PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.
Detailed Description This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: PF-04191834
    100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
  • Drug: PF-04191834 placebo
    Matching PF-04191834 placebo tablets to be administered BID for two weeks
  • Drug: Naproxen placebo
    Matching naproxen placebo tablets to be administered BID for 4 weeks
  • Drug: Naproxen
    Naproxen 500 mg tablet administered BID for a total of four weeks
Study Arms  ICMJE
  • Experimental: PF-04191834 followed by placebo
    PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo.
    Interventions:
    • Drug: PF-04191834
    • Drug: PF-04191834 placebo
    • Drug: Naproxen placebo
  • Experimental: Placebo followed by PF-04191834
    Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo.
    Interventions:
    • Drug: PF-04191834 placebo
    • Drug: PF-04191834
    • Drug: Naproxen placebo
  • Experimental: PF-04191834+Naproxen followed by Naproxen
    PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo
    Interventions:
    • Drug: PF-04191834
    • Drug: Naproxen
    • Drug: PF-04191834 placebo
  • Experimental: Naproxen followed by PF-04191834+Naproxen
    Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID
    Interventions:
    • Drug: Naproxen
    • Drug: PF-04191834 placebo
    • Drug: PF-04191834
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 17, 2010)
190
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray
  • Subjects must be willing and able to stop all current pain therapy for the duration of the study
  • Subjects must be willing and able to complete a daily diary

Exclusion Criteria:

  • BMI of >39 kg/m2
  • Known allergy or hypersensitivity to naproxen
  • Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (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 Canada,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01147458
Other Study ID Numbers  ICMJE B0041007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2013

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