A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee

April 22, 2011 updated by: Pfizer

A 2 Week, Randomized, Double Blind, Placebo And Positive Controlled, Parallel Group, Multicentre Study To Assess The Efficacy And Tolerability Of PF-00592379 In Patients With Moderate To Severe Pain Due To Osteoarthritis

The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

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
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Pfizer Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Pfizer Investigational Site
      • Fair Oaks, California, United States, 95628
        • Pfizer Investigational Site
      • Orangevale, California, United States, 95662
        • Pfizer Investigational Site
      • Roseville, California, United States, 95661
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95825
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Pfizer Investigational Site
      • DeLand, Florida, United States, 32720
        • Pfizer Investigational Site
      • Hollywood, Florida, United States, 33021
        • Pfizer Investigational Site
      • Longwood, Florida, United States, 32779
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33186
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Pfizer Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10022-1009
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45227
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • 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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female of any race
  • Between the ages of 18 and 75 years
  • Knee Pain due to osteoarthritis

Exclusion Criteria:

  • Pregnant
  • Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to baseline
  • History of malignancy, convulsions, chronic infections, arthroscopy of the worst knee within the past year

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo: oral for 2 weeks.
Active Comparator: Oxycodone
Drug: Oxycodone
Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
Experimental: PF-00592379
Drug: PF-000592379
PF-00592379: oral, 30 mg, once a day for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the pain score averaged over the last week of treatment
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment
Time Frame: 2 weeks
2 weeks
Patient Global Impression of Change
Time Frame: 2 weeks
2 weeks
Patients Global Assessment of Osteoarthritis
Time Frame: 2 weeks
2 weeks
Pharmacokinetic trough levels
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

June 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 6, 2007

First Submitted That Met QC Criteria

June 6, 2007

First Posted (Estimate)

June 8, 2007

Study Record Updates

Last Update Posted (Estimate)

April 29, 2011

Last Update Submitted That Met QC Criteria

April 22, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A7771010

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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