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

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ClinicalTrials.gov Identifier: NCT01102660
Recruitment Status : Completed
First Posted : April 13, 2010
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: PH-797804 Drug: Placebo Drug: Naproxen Drug: Naproxen + PH-797804 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011


Arm Intervention/treatment
Treatment Sequence 1 Drug: PH-797804
Tablet, 6 mg once daily for 2 weeks

Drug: Placebo
Tablet, 0 mg once daily for 2 weeks

Treatment Sequence 2 Drug: Placebo
Tablet, 0 mg once daily for 2 weeks

Drug: PH-797804
Tablet, 6 mg once daily for 2 weeks

Treatment Sequence 3 Drug: Naproxen
Tablet, 500 mg twice daily for 2 weeks

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

Treatment Sequence 4 Drug: Naproxen + PH-797804
Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks

Drug: Naproxen
Tablet, 500 mg twice daily for 2 weeks




Primary Outcome Measures :
  1. Western Ontario & McMaster Osteoarthritis Index Pain Score [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Western Ontario & McMaster Osteoarthritis Index Stiffness Score [ Time Frame: 2 weeks ]
  2. Western Ontario & McMaster Osteoarthritis Index Physical Function Score [ Time Frame: 2 weeks ]
  3. Western Ontario & McMaster Osteoarthritis Index Total Score [ Time Frame: 2 weeks ]
  4. Daily Pain Rating Scale [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102660


Locations
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United States, California
Pfizer Investigational Site
Paramount, California, United States, 90723
Pfizer Investigational Site
Spring Valley, California, United States, 91978
Pfizer Investigational Site
Valley Village, California, United States, 91607
United States, Florida
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32117
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
Pfizer Investigational Site
Plantation, Florida, United States, 33317
Pfizer Investigational Site
Plantation, Florida, United States, 33324
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Illinois
Pfizer Investigational Site
Gurnee, Illinois, United States, 60031
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Overland Park, Kansas, United States, 66215
Pfizer Investigational Site
Prairie Village, Kansas, United States, 66206
Pfizer Investigational Site
Wichita, Kansas, United States, 67206
United States, Massachusetts
Pfizer Investigational Site
Fall River, Massachusetts, United States, 02721
Pfizer Investigational Site
Hyannis, Massachusetts, United States, 02601
Pfizer Investigational Site
New Bedford, Massachusetts, United States, 02740
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14609
United States, North Carolina
Pfizer Investigational Site
Wilmington, North Carolina, United States, 28401
United States, Ohio
Pfizer Investigational Site
Kettering, Ohio, United States, 45429
United States, Rhode Island
Pfizer Investigational Site
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
United States, Tennessee
Pfizer Investigational Site
New Tazewell, Tennessee, United States, 37825
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75235
Pfizer Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01102660    
Other Study ID Numbers: A6631026
First Posted: April 13, 2010    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Pfizer:
Knee osteoarthritis
clinical trial
cross-over
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action