Study Stopped
Met criteria for study futility at interim analysis
A 2 Week Blinded Study For Pain Due To Arthritis Of The Knee
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
1 other identifier
interventional
113
1 country
21
Brief Summary
The primary aim is to assess if PF-00592379 is able to reduce pain in patients with osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2007
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 6, 2007
CompletedFirst Posted
Study publicly available on registry
June 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedApril 29, 2011
April 1, 2011
6 months
June 6, 2007
April 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in the pain score averaged over the last week of treatment
2 weeks
Secondary Outcomes (4)
Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment
2 weeks
Patient Global Impression of Change
2 weeks
Patients Global Assessment of Osteoarthritis
2 weeks
Pharmacokinetic trough levels
2 weeks
Study Arms (3)
Oxycodone
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORPF-00592379
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female of any race
- Between the ages of 18 and 75 years
- Knee Pain due to osteoarthritis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (21)
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Pfizer Investigational Site
Tucson, Arizona, 85741, 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
Sacramento, California, 95825, United States
Pfizer Investigational Site
Boca Raton, Florida, 33486, United States
Pfizer Investigational Site
DeLand, Florida, 32720, United States
Pfizer Investigational Site
Hollywood, Florida, 33021, United States
Pfizer Investigational Site
Longwood, Florida, 32779, United States
Pfizer Investigational Site
Miami, Florida, 33186, United States
Pfizer Investigational Site
Louisville, Kentucky, 40213, United States
Pfizer Investigational Site
Madisonville, Kentucky, 42431, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 6, 2007
First Posted
June 8, 2007
Study Start
June 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
April 29, 2011
Record last verified: 2011-04