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

Pfizer76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

PF-04457845DRUG

PF-04457845 4 mg tablet once daily / matched placebo

PF-04457845DRUG

PF-04457845 4 mg tablet once daily / matched placebo

NaproxenDRUG

Naproxen 500 mg tablet twice daily / matched placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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

Time frame: 8 weeks

To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis.

Time frame: 10 weeks

Secondary Outcomes

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.

Time frame: 8 weeks

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.

Time frame: 8 weeks

Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee.

Time frame: 8 weeks

Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Importance weighted Total WOMAC score in patients with osteoarthritis of the knee.

Time frame: 8 weeks

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.

Time frame: 8 weeks

Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment.

Data from ClinicalTrials.gov

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