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

This study has been terminated.
(Met criteria for study futility at interim analysis)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00483977
First received: June 6, 2007
Last updated: April 22, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Drug: Oxycodone
Drug: Placebo
Drug: PF-000592379
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in the pain score averaged over the last week of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Patients Global Assessment of Osteoarthritis [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetic trough levels [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483977

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00483977     History of Changes
Other Study ID Numbers: A7771010
Study First Received: June 6, 2007
Last Updated: April 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 17, 2014