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

Phase 2

Terminated

• Conditions: Osteoarthritis
• Interventions: Drug: Placebo; Drug: PF-000592379; Drug: Oxycodone

• Registration Number: NCT00483977
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-06
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-08
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Disposition First Submitted: 2009-04-06
• Disposition First Submitted QC: 2010-04-12
• Disposition First Posted: 2010-04-14
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-22
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PF-00592379	PF-000592379	-
Oxycodone	Oxycodone	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the pain score averaged over the last week of treatment	2 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Richmond, Virginia, United States