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

August 20, 2014 updated by: Pfizer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Paramount, California, United States, 90723
        • Pfizer Investigational Site
      • Spring Valley, California, United States, 91978
        • Pfizer Investigational Site
      • Valley Village, California, United States, 91607
        • Pfizer Investigational Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Pfizer Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33324
        • Pfizer Investigational Site
      • Plantation, Florida, United States, 33317
        • Pfizer Investigational Site
      • South Miami, Florida, United States, 33143
        • Pfizer Investigational Site
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
      • Overland Park, Kansas, United States, 66215
        • Pfizer Investigational Site
      • Prairie Village, Kansas, United States, 66206
        • Pfizer Investigational Site
      • Wichita, Kansas, United States, 67206
        • Pfizer Investigational Site
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
        • Pfizer Investigational Site
      • Hyannis, Massachusetts, United States, 02601
        • Pfizer Investigational Site
      • New Bedford, Massachusetts, United States, 02740
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • New York
      • Rochester, New York, United States, 14609
        • Pfizer Investigational Site
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Pfizer Investigational Site
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Pfizer Investigational Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Pfizer Investigational Site
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
    • Tennessee
      • New Tazewell, Tennessee, United States, 37825
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78209
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Treatment Sequence 1
Drug: PH-797804
Tablet, 6 mg once daily for 2 weeks
Drug: Placebo
Tablet, 0 mg once daily for 2 weeks
OTHER: Treatment Sequence 2
Drug: PH-797804
Tablet, 6 mg once daily for 2 weeks
Drug: Placebo
Tablet, 0 mg once daily for 2 weeks
OTHER: Treatment Sequence 3
Drug: Naproxen
Tablet, 500 mg twice daily for 2 weeks
Drug: Naproxen + PH-797804
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
OTHER: Treatment Sequence 4
Drug: Naproxen
Tablet, 500 mg twice daily for 2 weeks
Drug: Naproxen + PH-797804
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Western Ontario & McMaster Osteoarthritis Index Pain Score
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

April 12, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (ESTIMATE)

April 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6631026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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