Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
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
1 other identifier
interventional
172
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedAugust 22, 2014
August 1, 2014
9 months
April 12, 2010
August 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Western Ontario & McMaster Osteoarthritis Index Pain Score
2 weeks
Secondary Outcomes (4)
Western Ontario & McMaster Osteoarthritis Index Stiffness Score
2 weeks
Western Ontario & McMaster Osteoarthritis Index Physical Function Score
2 weeks
Western Ontario & McMaster Osteoarthritis Index Total Score
2 weeks
Daily Pain Rating Scale
2 weeks
Study Arms (4)
Treatment Sequence 1
OTHERTreatment Sequence 2
OTHERTreatment Sequence 3
OTHERTreatment Sequence 4
OTHERInterventions
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (26)
Pfizer Investigational Site
Paramount, California, 90723, United States
Pfizer Investigational Site
Spring Valley, California, 91978, United States
Pfizer Investigational Site
Valley Village, California, 91607, United States
Pfizer Investigational Site
Daytona Beach, Florida, 32117, United States
Pfizer Investigational Site
Ormond Beach, Florida, 32174, United States
Pfizer Investigational Site
Plantation, Florida, 33317, United States
Pfizer Investigational Site
Plantation, Florida, 33324, United States
Pfizer Investigational Site
South Miami, Florida, 33143, United States
Pfizer Investigational Site
Gurnee, Illinois, 60031, United States
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Pfizer Investigational Site
Overland Park, Kansas, 66212, United States
Pfizer Investigational Site
Overland Park, Kansas, 66215, United States
Pfizer Investigational Site
Prairie Village, Kansas, 66206, United States
Pfizer Investigational Site
Wichita, Kansas, 67206, United States
Pfizer Investigational Site
Fall River, Massachusetts, 02721, United States
Pfizer Investigational Site
Hyannis, Massachusetts, 02601, United States
Pfizer Investigational Site
New Bedford, Massachusetts, 02740, United States
Pfizer Investigational Site
St Louis, Missouri, 63141, United States
Pfizer Investigational Site
Rochester, New York, 14609, United States
Pfizer Investigational Site
Wilmington, North Carolina, 28401, United States
Pfizer Investigational Site
Kettering, Ohio, 45429, United States
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
Pfizer Investigational Site
New Tazewell, Tennessee, 37825, United States
Pfizer Investigational Site
Dallas, Texas, 75235, United States
Pfizer Investigational Site
San Antonio, Texas, 78209, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2010
First Posted
April 13, 2010
Study Start
May 1, 2010
Primary Completion
February 1, 2011
Study Completion
March 1, 2011
Last Updated
August 22, 2014
Record last verified: 2014-08