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NCT00981357 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00981357
Other study ID # B0541004
Secondary ID 2009-014734-16
Status Completed
Phase Phase 2
First received September 21, 2009
Last updated September 13, 2017
Start date November 2009
Est. completion date May 2010

Study information
Verified date September 2017
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PF-04457845
PF-04457845 4 mg tablet once daily / matched placebo
• PF-04457845
PF-04457845 4 mg tablet once daily / matched placebo
• Naproxen
Naproxen 500 mg tablet twice daily / matched placebo
• Naproxen
Naproxen 500 mg tablet twice daily / matched placebo

Locations
Country Name City State
Canada Diex Research Inc. Sherbrooke Quebec
Sweden Centrum for klinisk provning Goteborg
United States Arthritis & Rheumatic Care Center Miami Florida
United States Miami Research Associates Miami Florida
United States Vince and Associates Clinical Research Overland Park Kansas
United States Vince and Associates Clinical Research Overland Park Kansas
United States CEDRA Clinical Research, LLC San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the efficacy of PF-04457845 (administered QD) versus placebo in relieving pain as measured by the WOMAC Pain sub-score in patients with osteoarthritis of the knee 8 weeks
Primary To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis. 10 weeks
Secondary Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Stiffness domain score (Likert scale for 2 items, overall score ranges from 0-8) in patients with osteoarthritis of the knee. 8 weeks
Secondary Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Physical Function domain score (Likert scale for 17 items, overall score ranges from 0-68) in patients with osteoarthritis of the knee. 8 weeks
Secondary Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee. 8 weeks
Secondary Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee. 8 weeks
Secondary Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Daily pain diary over weeks 1 and 2 of each treatment period using an 11-point Numeric Rating Scale (NRS) in patients with osteoarthritis of the knee. 8 weeks
Secondary Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment. 8 weeks
Secondary Summary of plasma concentrations of PF-04457845. 8 weeks
Secondary Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis. 8 weeks
Secondary Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis. 8 weeks
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