Clinical trial NCT00483977: A 2 Week Blinded Study For Pain Due To Arthritis 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline in the pain score averaged over the last week of treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score - change from baseline to end of treatment
timeFrame: 2 weeks
measure: Patient Global Impression of Change
timeFrame: 2 weeks
measure: Patients Global Assessment of Osteoarthritis
timeFrame: 2 weeks
measure: Pharmacokinetic trough levels
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Carmichael
country: United States
facility: Pfizer Investigational Site
state: California
city: Fair Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Orangevale
country: United States
facility: Pfizer Investigational Site
state: California
city: Roseville
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Longwood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: