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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00483977
Recruitment Status : Terminated (Met criteria for study futility at interim analysis)
First Posted : June 8, 2007
Last Update Posted : April 29, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Oxycodone Drug: Placebo Drug: PF-000592379 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Oxycodone

Arm Intervention/treatment
Active Comparator: Oxycodone Drug: Oxycodone
Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo: oral for 2 weeks.

Experimental: PF-00592379 Drug: PF-000592379
PF-00592379: oral, 30 mg, once a day for 2 weeks

Primary Outcome Measures :
  1. Change from baseline in the pain score averaged over the last week of treatment [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment [ Time Frame: 2 weeks ]
  2. Patient Global Impression of Change [ Time Frame: 2 weeks ]
  3. Patients Global Assessment of Osteoarthritis [ Time Frame: 2 weeks ]
  4. Pharmacokinetic trough levels [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00483977

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United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Pfizer Investigational Site
Tucson, Arizona, United States, 85741
United States, California
Pfizer Investigational Site
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
United States, Florida
Pfizer Investigational Site
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
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40213
Pfizer Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89146
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10022-1009
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27704
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45227
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc. Identifier: NCT00483977    
Other Study ID Numbers: A7771010
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents