Last updated date
ABOUT THIS STUDY
The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared
with naproxen and placebo in patients with osteoarthritis.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Arthritis, Osteoarthritis
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2
Exclusion Criteria
Show details
- Pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurologic or cardiac disease
NEED INFO?
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Arthritis, OsteoarthritisTanezumab in Osteoarthritis of the Knee
NCT00733902
- Phoenix, Arizona
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- Newark, Delaware
- Clearwater, Florida
- DeLand, Florida
- Delray Beach, Florida
- Jacksonville, Florida
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- Orlando, Florida
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- Pinellas Park, Florida
- Port Orange, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Decatur, Georgia
- Fort Valley, Georgia
- Woodstock, Georgia
- Boise, Idaho
- Springfield, Illinois
- South Bend, Indiana
- Valparaiso, Indiana
- Lexington, Kentucky
- Loiusville, Kentucky
- Baton Rouge, Louisiana
- Monroe, Louisiana
- Auburn, Maine
- Frederick, Maryland
- Wheaton, Maryland
- Mansfield, Massachusetts
- Peabody, Massachusetts
- Worcester, Massachusetts
- Ann Arbor, Michigan
- St. Clair Shores, Michigan
- Edina, Minnesota
- St. Louis, Missouri
- Las Vegas,, Nevada
- Berlin, New Jersey
- Albuquerque, New Mexico
- Albuquerque, New Mexico
- New York, New York
- Plainview, New York
- Rochester, New York
- Charlotte, North Carolina
- Greensboro, North Carolina
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- Cincinnati, Ohio
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- Oklahoma City, Oklahoma
- Portland, Oregon
- Bethlehem, Pennsylvania
- Downingtown, Pennsylvania
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- Rapid City, South Dakota
- Johnson City, Tennessee
- Austin, Texas
- Dallas, Texas
- San Antonio, Texas
- San Antonio, Texas
- Charlottesville, Virginia
- Yakima, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Arthritis, OsteoarthritisTanezumab In Osteoarthritis Of The Knee (2)
NCT00830063
- Anniston, Alabama
- Mesa, Arizona
- Paradise Valley, Arizona
- Peoria, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Tempe, Arizona
- Tucson, Arizona
- Tuscon, Arizona
- Hot Springs, Arkansas
- Beverly Hills, California
- Fresno, California
- Huntington Beach, California
- Sacramento, California
- Thousand Oaks, California
- Stamford, Connecticut
- Newark, Delaware
- Clearwater, Florida
- Clearwater, Florida
- Coral Gables, Florida
- DeLand, Florida
- Jacksonville, Florida
- Longwood, Florida
- Miami, Florida
- Palm Harbor, Florida
- Pembroke Pines, Florida
- Port Orange, Florida
- Tamarac, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Decatur, Georgia
- Marietta, Georgia
- Woodstock, Georgia
- Woodstock, Georgia
- Boise, Idaho
- Chicago, Illinois
- Chicago, Illinois
- Morton Grove, Illinois
- Morton, Illinois
- Springfield, Illinois
- Valparaiso, Indiana
- Ames, Iowa
- West Des Moines, Iowa
- Wichita, Kansas
- Louisville, Kentucky
- Baton Rouge, Louisiana
- Auburn, Maine
- Frederick, Maryland
- Wheaton, Maryland
- Worcester, Massachusetts
- St. Clair Shores, Michigan
- Edina, Minnesota
- St. Louis, Missouri
- Omaha, Nebraska
- Las Vegas,, Nevada
- Las Vegas, Nevada
- Berlin, New Jersey
- Albuquerque, New Mexico
- Albuquerque, New Mexico
- New York, New York
- Rochester, New York
- Roslyn, New York
- Charlotte, North Carolina
- Greensboro, North Carolina
- Fargo, North Dakota
- Cincinnati, Ohio
- Middleburg Heights, Ohio
- Zanesville, Ohio
- Oklahoma City, Oklahoma
- Duncansville, Pennsylvania
- West Reading, Pennsylvania
- Mount Pleasant, South Carolina
- Rapid City, South Dakota
- Johnson City, Tennessee
- Kingsport, Tennessee
- Austin, Texas
- Dallas, Texas
- Houston, Texas
- Houston, Texas
- San Antonio, Texas
- San Antonio, Texas
- Orem, Utah
- Norfolk, Virginia
- Portsmouth, Virginia
- Yakima, Washington
ALL GENDERS
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Tanezumab In Osteoarthritis Of The Knee (2) | |||
Official Title ICMJE | A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee | |||
Brief Summary | The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * |
| |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 848 | |||
Original Estimated Enrollment ICMJE | 800 | |||
Actual Study Completion Date ICMJE | July 2010 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00830063 | |||
Other Study ID Numbers ICMJE | A4091015 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | June 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |