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NCT00483977 Clinical Trial

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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00483977
Other study ID # A7771010
Secondary ID
Status Terminated
Phase Phase 2
First received June 6, 2007
Last updated April 22, 2011
Start date June 2007
Est. completion date December 2007

Study information
Verified date April 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 113
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Oxycodone
Oxycodone: oral controlled release, 20 mg, twice a day for 2 weeks
• Placebo
Placebo: oral for 2 weeks.
• PF-000592379
PF-00592379: oral, 30 mg, once a day for 2 weeks

Locations
Country Name City State
United States Pfizer Investigational Site Boca Raton Florida
United States Pfizer Investigational Site Carmichael California
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site DeLand Florida
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Fair Oaks California
United States Pfizer Investigational Site Hollywood Florida
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Longwood Florida
United States Pfizer Investigational Site Louisville Kentucky
United States Pfizer Investigational Site Madisonville Kentucky
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site Mobile Alabama
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Orangevale California
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Roseville California
United States Pfizer Investigational Site Sacramento California
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Tucson Arizona

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in the pain score averaged over the last week of treatment 2 weeks No
Secondary Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment 2 weeks No
Secondary Patient Global Impression of Change 2 weeks No
Secondary Patients Global Assessment of Osteoarthritis 2 weeks No
Secondary Pharmacokinetic trough levels 2 weeks No
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Active, not recruiting NCT02723929 - Effects of tDCS and tUS on Pain Perception in OA of the Knee
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