Clinical trial NCT00981357: A Study To Investigate Whether PF-04457845 Is Effective In Treating Pain, Is Safe And Tolerable In Patients With Osteoarthritis Of The Knee
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 8 weeks
measure: To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.
timeFrame: 10 weeks
Secondary outcomes:
measure: 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.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.
timeFrame: 8 weeks
measure: Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment.
timeFrame: 8 weeks
measure: Summary of plasma concentrations of PF-04457845.
timeFrame: 8 weeks
measure: Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis.
timeFrame: 8 weeks
measure: Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Arthritis & Rheumatic Care Center
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: San Antonio
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
city: Sherbrooke
country: Canada
facility: Diex Research Inc.
state: Quebec
city: Goteborg
country: Sweden
facility: Centrum for klinisk provning
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: