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A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

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NCT00981357

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Arthritis & Rheumatic Care Center
Miami, Florida, 33143 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 (OA) of the knee confirmed by X-ray

- Subjects must be willing and able to stop all current pain therapy for the duration of
study. (Limited and specific pain therapy will be available throughout the study)

- Subjects can be male or female between the ages of 18 and 75 years inclusive, but
female subjects must not be able become pregnant

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

- Subjects must not have any condition or medical history that might interfere with
their ability to complete the study assessments

NCT00981357
Pfizer
Completed
A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee

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A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
A Phase 2a Randomized, Double-blinded, Double Dummy, Placebo And Active Controlled, Two-way Cross-over, Flare-enriched Multi-centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A Fatty Acid Amide Hydrolase (Faah) Inhibitor Pf-04457845 In Patients With Osteoarthritis Of The Knee.
Inactivation of the FAAH (Fatty Acid Amide Hydrolase) enzyme has been shown to relieve pain and inflammation in animal studies. PF-04457845 has been shown to inactivate the FAAH enzyme in animals and healthy human volunteers. The purpose of this study is to evaluate whether PF-04457845 can inactivate the FAAH enzyme in patients experiencing pain due to OA and whether this results in these patients experiencing less pain.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • Drug: PF-04457845
    PF-04457845 4 mg tablet once daily / matched placebo
  • Drug: Naproxen
    Naproxen 500 mg tablet twice daily / matched placebo
  • Experimental: PF-04457845 followed by placebo
    Intervention: Drug: PF-04457845
  • Experimental: Placebo followed by PF-04457845
    Intervention: Drug: PF-04457845
  • Active Comparator: Naproxen followed by placebo
    Intervention: Drug: Naproxen
  • Active Comparator: Placebo followed by Naproxen
    Intervention: Drug: Naproxen
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have a diagnosis of Osteoarthritis (OA) of the knee confirmed by X-ray
  • Subjects must be willing and able to stop all current pain therapy for the duration of study. (Limited and specific pain therapy will be available throughout the study)
  • Subjects can be male or female between the ages of 18 and 75 years inclusive, but female subjects must not be able become pregnant

Exclusion Criteria:

  • Subjects must not have any condition or medical history that might interfere with their ability to complete the study assessments
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Sweden,   United States
South Africa
 
NCT00981357
B0541004
2009-014734-16 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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