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

Condition(s) targeted: Osteoarthritis

Intervention: Oxycodone (Drug); Placebo (Drug); PF-000592379 (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in the pain score averaged over the last week of treatment

Secondary outcome:

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment

Patient Global Impression of Change

Patients Global Assessment of Osteoarthritis

Pharmacokinetic trough levels

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

Male or female of any race, between the ages of 18 and 75 years inclusive 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.

Pfizer Investigational Site, Mobile, Alabama 36608, United States

Pfizer Investigational Site, Tucson, Arizona 85741, United States

Pfizer Investigational Site, Sacramento, California 95825, United States

Pfizer Investigational Site, Carmichael, California 95608, United States

Pfizer Investigational Site, Fair Oaks, California 95628, United States

Pfizer Investigational Site, Orangevale, California 95662, United States

Pfizer Investigational Site, Roseville, California 95661, United States

Pfizer Investigational Site, Hollywood, Florida 33021, United States

Pfizer Investigational Site, Longwood, Florida 32779, United States

Pfizer Investigational Site, DeLand, Florida 32720, United States

Pfizer Investigational Site, Miami, Florida 33186, United States

Pfizer Investigational Site, Boca Raton, Florida 33486, United States

Pfizer Investigational Site, Madisonville, Kentucky 42431, United States

Pfizer Investigational Site, Louisville, Kentucky 40213, United States

Pfizer Investigational Site, St. Louis, Missouri 63141, United States

Pfizer Investigational Site, Las Vegas, Nevada 89146, United States

Pfizer Investigational Site, New York, New York 10022-1009, United States

Pfizer Investigational Site, Durham, North Carolina 27704, United States

Pfizer Investigational Site, Cincinnati, Ohio 45227, United States

Pfizer Investigational Site, Cincinnati, Ohio 45242, United States

Pfizer Investigational Site, Richmond, Virginia 23294, United States

To obtain contact information for a study center near you, click here.

Starting date: July 2007
Ending date: December 2007
Last updated: January 9, 2008