Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

Pfizer172 enrolled

Overview

PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

172

Conditions

Osteoarthritis

Interventions

PH-797804DRUG

Tablet, 6 mg once daily for 2 weeks

PlaceboDRUG

Tablet, 0 mg once daily for 2 weeks

PlaceboDRUG

Tablet, 0 mg once daily for 2 weeks

PH-797804

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential. * Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2. Exclusion Criteria: * History of diseases other than osteoarthritis that may involve the index knee. * Other severe pain that impairs the assessment of osteoarthritis of pain. * Electrocardiogram abnormalities. * History of gastrointestinal disorders.

Locations (26)

Outcomes

Primary Outcomes

Western Ontario & McMaster Osteoarthritis Index Pain Score

Time frame: 2 weeks

Secondary Outcomes

Western Ontario & McMaster Osteoarthritis Index Stiffness Score

Time frame: 2 weeks

Western Ontario & McMaster Osteoarthritis Index Physical Function Score

Time frame: 2 weeks

Western Ontario & McMaster Osteoarthritis Index Total Score

Time frame: 2 weeks

Daily Pain Rating Scale

Time frame: 2 weeks

Data from ClinicalTrials.gov

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