A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00483977

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Oxycodone Oxycodone hydrochloride

U.S. FDA Resources

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:	July 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oxycodone: Active Comparator	Drug: Oxycodone Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
Placebo: Placebo Comparator	Drug: Placebo Placebo: oral for 2 weeks.
PF-00592379: Experimental	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
Sacramento, California, United States, 95825
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
United States, Florida
Pfizer Investigational Site
Hollywood, Florida, United States, 33021
Pfizer Investigational Site
Longwood, Florida, United States, 32779
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Miami, Florida, United States, 33186
Pfizer Investigational Site
Boca Raton, Florida, United States, 33486
United States, Kentucky
Pfizer Investigational Site
Madisonville, Kentucky, United States, 42431
Pfizer Investigational Site
Louisville, Kentucky, United States, 40213
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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trials Disclosure Group )
Study ID Numbers:	A7771010
Study First Received:	June 6, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00483977 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoarthritis
Joint Diseases
Oxycodone
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Rheumatic Diseases
Pharmacologic Actions

Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Arthritis
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010