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Completed

NCT Number: NCT01102660

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

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Paramount, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PH-797804

Drug

Tablet, 6 mg once daily for 2 weeks

Placebo

Drug

Tablet, 0 mg once daily for 2 weeks

Naproxen

Drug

Tablet, 500 mg twice daily for 2 weeks

Naproxen + PH-797804

Drug

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

Primary outcomes

  1. Western Ontario & McMaster Osteoarthritis Index Pain Score

    Time frame: 2 weeks

Secondary outcomes

  1. Western Ontario & McMaster Osteoarthritis Index Stiffness Score

    Time frame: 2 weeks

  2. Western Ontario & McMaster Osteoarthritis Index Physical Function Score

    Time frame: 2 weeks

  3. Western Ontario & McMaster Osteoarthritis Index Total Score

    Time frame: 2 weeks

  4. Daily Pain Rating Scale

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2010
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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