Clinical trial NCT01102660: Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo And Active Controlled Two Period Four Treatment Cross-Over Clinical Trial To Examine The Pain Relief Of PH-797804 Alone Or With Naproxen In Subjects With Flare-Enriched Osteoarthritis Of The Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Knee osteoarthritis
clinical trial
cross-over
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: PH-797804 is a potent inhibitor of inflammatory mediators that have a potential role in pain signalling following nerve injury and inflammation. Blocking such mediators may potentially have a therapeutic benefit by reducing pain.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects between, and including, the ages of 18 and 75 years. Females must be of non-childbearing potential.
* Diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray grade of ≥2.

Exclusion Criteria:

* History of diseases other than osteoarthritis that may involve the index knee.
* Other severe pain that impairs the assessment of osteoarthritis of pain.
* Electrocardiogram abnormalities.
* History of gastrointestinal disorders.

Primary outcomes:
measure: Western Ontario & McMaster Osteoarthritis Index Pain Score
timeFrame: 2 weeks
Secondary outcomes:
measure: Western Ontario & McMaster Osteoarthritis Index Stiffness Score
timeFrame: 2 weeks
measure: Western Ontario & McMaster Osteoarthritis Index Physical Function Score
timeFrame: 2 weeks
measure: Western Ontario & McMaster Osteoarthritis Index Total Score
timeFrame: 2 weeks
measure: Daily Pain Rating Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Paramount
country: United States
facility: Pfizer Investigational Site
state: California
city: Spring Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Valley Village
country: United States
facility: Pfizer Investigational Site
state: California
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gurnee
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Prairie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Fall River
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Hyannis
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New Bedford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Pawtucket
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Mt. Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: New Tazewell
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: