Clinical Trial to Examine the Pain Relief of PH-797804 Alone Or With Naproxen in Subjects With Osteoarthritis of the Knee
NCT ID: NCT01102660
Last Updated: 2014-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
172 participants
INTERVENTIONAL
2010-05-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Treatment Sequence 1
PH-797804
Tablet, 6 mg once daily for 2 weeks
Placebo
Tablet, 0 mg once daily for 2 weeks
Treatment Sequence 2
Placebo
Tablet, 0 mg once daily for 2 weeks
PH-797804
Tablet, 6 mg once daily for 2 weeks
Treatment Sequence 3
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
Treatment Sequence 4
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* Other severe pain that impairs the assessment of osteoarthritis of pain.
* Electrocardiogram abnormalities.
* History of gastrointestinal disorders.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Paramount, California, United States
Pfizer Investigational Site
Spring Valley, California, United States
Pfizer Investigational Site
Valley Village, California, United States
Pfizer Investigational Site
Daytona Beach, Florida, United States
Pfizer Investigational Site
Ormond Beach, Florida, United States
Pfizer Investigational Site
Plantation, Florida, United States
Pfizer Investigational Site
Plantation, Florida, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
Gurnee, Illinois, 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
Prairie Village, Kansas, United States
Pfizer Investigational Site
Wichita, Kansas, United States
Pfizer Investigational Site
Fall River, Massachusetts, United States
Pfizer Investigational Site
Hyannis, Massachusetts, United States
Pfizer Investigational Site
New Bedford, Massachusetts, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Wilmington, North Carolina, United States
Pfizer Investigational Site
Kettering, Ohio, United States
Pfizer Investigational Site
Pawtucket, Rhode Island, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States
Pfizer Investigational Site
New Tazewell, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6631026
Identifier Type: -
Identifier Source: org_study_id
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