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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis

Treatments: Drug: Placebo; Drug: Naproxen + PH-797804; Drug: PH-797804; Drug: Naproxen

Study type: Interventional

Funder types: Industry

Identifiers

NCT01102660

A6631026

Details and patient eligibility

About

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.

Enrollment: 172 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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172 participants in 4 patient groups

Treatment Sequence 1

Other group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PH-797804

Drug: PH-797804

Treatment Sequence 2

Other group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: PH-797804

Drug: PH-797804

Treatment Sequence 3

Other group

Treatment:

Drug: Naproxen

Drug: Naproxen + PH-797804

Drug: Naproxen + PH-797804

Drug: Naproxen

Treatment Sequence 4

Other group

Treatment:

Drug: Naproxen

Drug: Naproxen + PH-797804

Drug: Naproxen + PH-797804

Drug: Naproxen