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 |
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Recruitment Status :
Completed
First Posted : April 13, 2010
Last Update Posted : August 22, 2014
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
| 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 :
- Western Ontario & McMaster Osteoarthritis Index Pain Score [ Time Frame: 2 weeks ]
Secondary Outcome Measures :
- Western Ontario & McMaster Osteoarthritis Index Stiffness Score [ Time Frame: 2 weeks ]
- Western Ontario & McMaster Osteoarthritis Index Physical Function Score [ Time Frame: 2 weeks ]
- Western Ontario & McMaster Osteoarthritis Index Total Score [ Time Frame: 2 weeks ]
- Daily Pain Rating Scale [ Time Frame: 2 weeks ]
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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
| 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
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| 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 |