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NCT01102660 Clinical Trial

Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01102660
Other study ID # A6631026
Secondary ID
Status Completed
Phase Phase 2
First received April 12, 2010
Last updated August 20, 2014
Start date May 2010
Est. completion date March 2011

Study information
Verified date August 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 172
Est. completion date March 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PH-797804
Tablet, 6 mg once daily for 2 weeks
• Placebo
Tablet, 0 mg once daily for 2 weeks
• Placebo
Tablet, 0 mg once daily for 2 weeks
• PH-797804
Tablet, 6 mg once daily for 2 weeks
• Naproxen
Tablet, 500 mg twice daily for 2 weeks
• Naproxen + PH-797804
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
• Naproxen + PH-797804
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
• Naproxen
Tablet, 500 mg twice daily for 2 weeks

Locations
Country Name City State
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Daytona Beach Florida
United States Pfizer Investigational Site Fall River Massachusetts
United States Pfizer Investigational Site Gurnee Illinois
United States Pfizer Investigational Site Hyannis Massachusetts
United States Pfizer Investigational Site Kettering Ohio
United States Pfizer Investigational Site Mt. Pleasant South Carolina
United States Pfizer Investigational Site New Bedford Massachusetts
United States Pfizer Investigational Site New Tazewell Tennessee
United States Pfizer Investigational Site Ormond Beach Florida
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Paramount California
United States Pfizer Investigational Site Pawtucket Rhode Island
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Prairie Village Kansas
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site South Miami Florida
United States Pfizer Investigational Site Spring Valley California
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Valley Village California
United States Pfizer Investigational Site Wichita Kansas
United States Pfizer Investigational Site Wilmington North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Western Ontario & McMaster Osteoarthritis Index Pain Score 2 weeks No
Secondary Western Ontario & McMaster Osteoarthritis Index Stiffness Score 2 weeks No
Secondary Western Ontario & McMaster Osteoarthritis Index Physical Function Score 2 weeks No
Secondary Western Ontario & McMaster Osteoarthritis Index Total Score 2 weeks No
Secondary Daily Pain Rating Scale 2 weeks No
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