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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Naproxen; Drug: PF-04457845

Study type: Interventional

Funder types: Industry

Identifiers

NCT00981357

B0541004

2009-014734-16 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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76 participants in 4 patient groups

PF-04457845 followed by placebo

Experimental group

Treatment:

Drug: PF-04457845

Drug: PF-04457845

Placebo followed by PF-04457845

Experimental group

Treatment:

Drug: PF-04457845

Drug: PF-04457845

Naproxen followed by placebo

Active Comparator group

Treatment:

Drug: Naproxen

Drug: Naproxen

Placebo followed by Naproxen

Active Comparator group

Treatment:

Drug: Naproxen

Drug: Naproxen