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

Last updated on November 13, 2019

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Study Location
Pfizer Investigational Site
Peoria, Arizona, 85381 United States
Contact
1-800-718-1021
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

NCT01147458
Pfizer
Terminated
A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

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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 SummaryPF-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 DescriptionThis 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 DateFebruary 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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