A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Naproxen placebo; Drug: PF-04191834 placebo; Drug: PF-04191834; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01147458

B0041007

Details and patient eligibility

About

PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.

Full description

This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication.

Enrollment: 190 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray
• Subjects must be willing and able to stop all current pain therapy for the duration of the study
• Subjects must be willing and able to complete a daily diary

Exclusion criteria

• BMI of >39 kg/m2
• Known allergy or hypersensitivity to naproxen
• Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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190 participants in 4 patient groups

PF-04191834 followed by placebo

Experimental group

Description:

PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo.

Treatment:

Drug: PF-04191834

Drug: PF-04191834 placebo

Drug: PF-04191834 placebo

Drug: Naproxen placebo

Drug: Naproxen placebo

Drug: PF-04191834

Drug: PF-04191834

Drug: PF-04191834 placebo

Drug: PF-04191834 placebo

Drug: PF-04191834

Placebo followed by PF-04191834

Experimental group

Description:

Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo.

Treatment:

Drug: PF-04191834

Drug: PF-04191834 placebo

Drug: PF-04191834 placebo

Drug: Naproxen placebo

Drug: Naproxen placebo

Drug: PF-04191834

Drug: PF-04191834

Drug: PF-04191834 placebo

Drug: PF-04191834 placebo

Drug: PF-04191834

PF-04191834+Naproxen followed by Naproxen

Experimental group

Description:

PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo

Treatment:

Drug: PF-04191834

Drug: PF-04191834 placebo

Drug: PF-04191834 placebo

Drug: Naproxen

Drug: PF-04191834

Drug: PF-04191834

Drug: Naproxen

Drug: PF-04191834 placebo

Drug: PF-04191834 placebo

Drug: PF-04191834

Naproxen followed by PF-04191834+Naproxen

Experimental group

Description:

Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID

Treatment:

Drug: PF-04191834

Drug: PF-04191834 placebo

Drug: PF-04191834 placebo

Drug: Naproxen

Drug: PF-04191834

Drug: PF-04191834

Drug: Naproxen

Drug: PF-04191834 placebo

Drug: PF-04191834 placebo

Drug: PF-04191834