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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00981357

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: PF-04457845 Drug: Naproxen	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of PF-04457845 in patients with osteoarthritis. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Efficacy of PF-04457845 (administered QD) versus placebo as measured by the Subjects' use of rescue medication on either treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Summary of plasma concentrations of PF-04457845. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Residual FAAH activity in leukocytes for subjects recruited prior to the interim analysis. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Plasma fatty acid amide levels (OEA, PEA, LEA and AEA) for subjects recruited prior to the interim analysis. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	76
Study Start Date:	November 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-04457845 followed by placebo	Drug: PF-04457845 PF-04457845 4 mg tablet once daily / matched placebo
Experimental: Placebo followed by PF-04457845	Drug: PF-04457845 PF-04457845 4 mg tablet once daily / matched placebo
Active Comparator: Naproxen followed by placebo	Drug: Naproxen Naproxen 500 mg tablet twice daily / matched placebo
Active Comparator: Placebo followed by Naproxen	Drug: Naproxen Naproxen 500 mg tablet twice daily / matched placebo

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981357

Locations

United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33143
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78217
Canada, Quebec
Pfizer Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Sweden
Pfizer Investigational Site
Goteborg, Sweden, 405 30

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00981357 History of Changes
Other Study ID Numbers:	B0541004
Study First Received:	September 21, 2009
Last Updated:	June 2, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Cross-over evaluate the efficacy of PF-04457845 in relieving pain due to osteoarthritis OA knee osteoarthritis of knee pain due to osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012