Tanezumab in Osteoarthritis of the Hip or Knee (2)
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00863304
First received: March 13, 2009
Last updated: May 2, 2011
Last verified: May 2011
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Purpose
Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Biological: tanezumab 10 mg Biological: tanezumab 5 mg Drug: naproxen Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study of the Analgesic Efficacy And Study of Tanezumab in Patients With Osteoarthritis Of The Hip or Knee |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- WOMAC function [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
- WOMAC pain [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
- Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Womac physical function [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
- Womac pain [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
- Patient Global Assessment of Osteoarthritis [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
- OMERACT-OARSI responder criteria [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
- SF-36 [ Time Frame: weeks 12 and 16 ] [ Designated as safety issue: No ]
- Daily NRS scores [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
- Safety (AEs, laboratory, ECGs, PEs, vital signs) [ Time Frame: all weeks ] [ Designated as safety issue: Yes ]
- Time to discontinuation [ Time Frame: all weeks ] [ Designated as safety issue: No ]
- Womac stiffness [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
- Treatment Response: Reduction in WOMAC Pain Subscale [ Time Frame: weeks 2, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
| Enrollment: | 849 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: tanezumab 10 mg
tanezumab 10 mg one dose at weeks 0 and 8
|
| Experimental: 2 |
Biological: tanezumab 5 mg
tanezumab 5 mg one dose at weeks 0 and 8
|
| Active Comparator: 3 |
Drug: naproxen
naproxen 1000 mg daily for 16 weeks
|
| Placebo Comparator: 4 |
Other: placebo
placebo to match tanezumab and naproxen dosing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2
Exclusion Criteria:
- pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychiatric disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863304
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35242 | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Mesa, Arizona, United States, 85206 | |
| Pfizer Investigational Site | |
| Mesa, Arizona, United States, 85213 | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85020 | |
| Pfizer Investigational Site | |
| Tempe, Arizona, United States, 85282 | |
| Pfizer Investigational Site | |
| Tuscon, Arizona, United States, 85705 | |
| United States, California | |
| Pfizer Investigational Site | |
| Chula Vista, California, United States, 91911 | |
| Pfizer Investigational Site | |
| Englewood, California, United States, 80113 | |
| Pfizer Investigational Site | |
| Fountain Valley, California, United States, 92708 | |
| Pfizer Investigational Site | |
| Fresno, California, United States, 93720 | |
| Pfizer Investigational Site | |
| Garden Grove, California, United States, 92843 | |
| Pfizer Investigational Site | |
| Lakewood, California, United States, 90712 | |
| Pfizer Investigational Site | |
| Lancaster, California, United States, 93534 | |
| Pfizer Investigational Site | |
| Long Beach, California, United States, 90807 | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90036 | |
| Pfizer Investigational Site | |
| Los Gatos, California, United States, 95032 | |
| Pfizer Investigational Site | |
| Reseda, California, United States, 91335 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92120 | |
| Pfizer Investigational Site | |
| Thousand Oaks, California, United States, 91360 | |
| Pfizer Investigational Site | |
| Westlake Village, California, United States, 91361 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Aurora, Colorado, United States, 80014 | |
| Pfizer Investigational Site | |
| Aurora, Colorado, United States, 80012 | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80209 | |
| Pfizer Investigational Site | |
| Englewood, Colorado, United States, 80110 | |
| Pfizer Investigational Site | |
| Englewood, Colorado, United States, 80113 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Norwalk, Connecticut, United States, 06851 | |
| Pfizer Investigational Site | |
| Stamford, Connecticut, United States, 06905 | |
| United States, Delaware | |
| Pfizer Investigational Site | |
| Lewes, Delaware, United States, 19958 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Bradenton, Florida, United States, 34202 | |
| Pfizer Investigational Site | |
| Doral, Florida, United States, 33166 | |
| Pfizer Investigational Site | |
| Fort Lauderdale, Florida, United States, 33334 | |
| Pfizer Investigational Site | |
| Ft. Lauderdale, Florida, United States, 33306 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33175 | |
| Pfizer Investigational Site | |
| Opa Locka, Florida, United States, 33054 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| Pfizer Investigational Site | |
| Sarasota, Florida, United States, 34232 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33614 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Augusta, Georgia, United States, 30909 | |
| Pfizer Investigational Site | |
| Blue Ridge, Georgia, United States, 30513 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Bloomington, Illinois, United States, 61701 | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60611-4542 | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60611 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40503 | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40213 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Hollywood, Maryland, United States, 20636 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Brockton, Massachusetts, United States, 02301 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Bay City, Michigan, United States, 48706 | |
| United States, Mississippi | |
| Pfizer Investigational Site | |
| Port Gibson, Mississippi, United States, 39150 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Springfield, Missouri, United States, 65807 | |
| Pfizer Investigational Site | |
| St. Louis, Missouri, United States, 63117 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Henderson, Nevada, United States, 89052 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89103 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89106 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Bronx, New York, United States, 10454 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10004 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Columbus, Ohio, United States, 43213 | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45439 | |
| Pfizer Investigational Site | |
| Middletown, Ohio, United States, 45042 | |
| Pfizer Investigational Site | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29406 | |
| Pfizer Investigational Site | |
| Clinton, South Carolina, United States, 29325 | |
| Pfizer Investigational Site | |
| Columbia, South Carolina, United States, 29204 | |
| Pfizer Investigational Site | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| Pfizer Investigational Site | |
| Rock Hill, South Carolina, United States, 29732 | |
| Pfizer Investigational Site | |
| Simpsonville, South Carolina, United States, 29681 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78746 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78745 | |
| Pfizer Investigational Site | |
| Grapevine, Texas, United States, 76051 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77070 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | |
| Lubbock, Texas, United States, 79410 | |
| Pfizer Investigational Site | |
| Sugar Land, Texas, United States, 77479 | |
| Pfizer Investigational Site | |
| Sugarland, Texas, United States, 77478 | |
| Pfizer Investigational Site | |
| Wichita Falls, Texas, United States, 63376 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84121 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84109 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Arlington, Virginia, United States, 22205 | |
| Pfizer Investigational Site | |
| Roanoke, Virginia, United States, 24018 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Selah, Washington, United States, 98942 | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99204-2336 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00863304 History of Changes |
| Other Study ID Numbers: | A4091018 |
| Study First Received: | March 13, 2009 |
| Last Updated: | May 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Hip 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 Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013