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

A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01102660

Enrollment

172

Registered

2010-04-13

Start date

2010-05-31

Completion date

2011-03-31

Last updated

2014-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Knee osteoarthritis, clinical trial, cross-over

Brief summary

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.

Interventions

DRUGPH-797804

Tablet, 6 mg once daily for 2 weeks

DRUGPlacebo

Tablet, 0 mg once daily for 2 weeks

DRUGNaproxen

Tablet, 500 mg twice daily for 2 weeks

DRUGNaproxen + PH-797804

Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Western Ontario & McMaster Osteoarthritis Index Pain Score	2 weeks

Secondary

Measure	Time frame
Western Ontario & McMaster Osteoarthritis Index Stiffness Score	2 weeks
Western Ontario & McMaster Osteoarthritis Index Physical Function Score	2 weeks
Western Ontario & McMaster Osteoarthritis Index Total Score	2 weeks
Daily Pain Rating Scale	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026