Osteoarthritis, Knee
Conditions
Keywords
Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis
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.
Interventions
DRUGNaproxen
Naproxen 500 mg tablet twice daily / matched placebo
DRUGPF-04457845
PF-04457845 4 mg tablet once daily / matched placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis. | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of PF-04457845 (administered QD) versus placebo as measured by the WOMAC Total Score in patients with osteoarthritis of the knee. | 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. | 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. | 8 weeks |
| 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 |
| Summary of plasma concentrations of PF-04457845. | 8 weeks |
| Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis. | 8 weeks |
| Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis. | 8 weeks |
| Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment. | 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. | 8 weeks |
Countries
Canada, Sweden, United States
Outcome results
None listed