Tanezumab in Osteoarthritis of the Hip or Knee (2)

Condition(s) targeted: Osteoarthritis

Intervention: tanezumab 10 mg (Biological); tanezumab 5 mg (Biological); naproxen (Drug); placebo (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

WOMAC function

WOMAC pain

Patient Global Assessment of Osteoarthritis

Secondary outcome:

Womac physical function

Womac pain

Patient Global Assessment of Osteoarthritis

OMERACT-OARSI responder criteria

SF-36

Daily NRS scores

Safety (AEs, laboratory, ECGs, PEs, vital signs)

Time to discontinuation

Womac stiffness

Treatment Response: Reduction in WOMAC Pain Subscale

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Mobile, Alabama 36608, United States; Recruiting

Pfizer Investigational Site, Birmingham, Alabama 35242, United States; Recruiting

Pfizer Investigational Site, Mesa, Arizona 85206, United States; Recruiting

Pfizer Investigational Site, Tuscon, Arizona 85705, United States; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85020, United States; Recruiting

Pfizer Investigational Site, Mesa, Arizona 85213, United States; Recruiting

Pfizer Investigational Site, Thousand Oaks, California 91360, United States; Recruiting

Pfizer Investigational Site, Chula Vista, California 91911, United States; Recruiting

Pfizer Investigational Site, Fresno, California 93720, United States; Recruiting

Pfizer Investigational Site, Westlake Village, California 91361, United States; Recruiting

Pfizer Investigational Site, Los Gatos, California 95032, United States; Recruiting

Pfizer Investigational Site, Fountain Valley, California 92708, United States; Recruiting

Pfizer Investigational Site, Sherman Oaks, California 91403, United States; Recruiting

Pfizer Investigational Site, Lakewood, California 90712, United States; Recruiting

Pfizer Investigational Site, Garden Grove, California 92843, United States; Recruiting

Pfizer Investigational Site, Denver, Colorado 80209, United States; Recruiting

Pfizer Investigational Site, Aurora, Colorado 80014, United States; Recruiting

Pfizer Investigational Site, Aurora, Colorado 80012, United States; Recruiting

Pfizer Investigational Site, Lewes, Delaware 19958, United States; Recruiting

Pfizer Investigational Site, Opa Locka, Florida 33054, United States; Recruiting

Pfizer Investigational Site, Sarasota, Florida 34233, United States; Recruiting

Pfizer Investigational Site, Miami, Florida 33175, United States; Recruiting

Pfizer Investigational Site, Orlando, Florida 32806, United States; Recruiting

Pfizer Investigational Site, Doral, Florida 33166, United States; Recruiting

Pfizer Investigational Site, Tampa, Florida 33614, United States; Recruiting

Pfizer Investigational Site, Ft. Lauderdale, Florida 33306, United States; Recruiting

Pfizer Investigational Site, Fort Lauderdale, Florida 33334, United States; Recruiting

Pfizer Investigational Site, Augusta, Georgia 30909, United States; Recruiting

Pfizer Investigational Site, Blue Ridge, Georgia 30513, United States; Recruiting

Pfizer Investigational Site, Evansville, Indiana 47714, United States; Recruiting

Pfizer Investigational Site, Louisville, Kentucky 40213, United States; Recruiting

Pfizer Investigational Site, Lexington, Kentucky 40503, United States; Recruiting

Pfizer Investigational Site, Baton Rouge, Louisiana 70808, United States; Recruiting

Pfizer Investigational Site, Hollywood, Maryland 20636, United States; Recruiting

Pfizer Investigational Site, Brockton, Massachusetts 02301, United States; Recruiting

Pfizer Investigational Site, Bay City, Michigan 48706, United States; Recruiting

Pfizer Investigational Site, Port Gibson, Mississippi 39150, United States; Recruiting

Pfizer Investigational Site, St. Louis, Missouri 63117, United States; Recruiting

Pfizer Investigational Site, Las Vegas, Nevada 89106, United States; Recruiting

Pfizer Investigational Site, Las Vegas, Nevada 89119, United States; Recruiting

Pfizer Investigational Site, Bronx, New York 10454, United States; Recruiting

Pfizer Investigational Site, New York, New York 10004, United States; Recruiting

Pfizer Investigational Site, Columbus, Ohio 43213, United States; Recruiting

Pfizer Investigational Site, Middletown, Ohio 45042, United States; Recruiting

Pfizer Investigational Site, Dayton, Ohio 45439, United States; Recruiting

Pfizer Investigational Site, Zanesville, Ohio 43701, United States; Recruiting

Pfizer Investigational Site, Oklahoma City, Oklahoma 73103, United States; Recruiting

Pfizer Investigational Site, Charleston, South Carolina 29406, United States; Recruiting

Pfizer Investigational Site, Mount Pleasant, South Carolina 29464, United States; Recruiting

Pfizer Investigational Site, Rock Hill, South Carolina 29732, United States; Recruiting

Pfizer Investigational Site, Columbia, South Carolina 29204, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77070, United States; Recruiting

Pfizer Investigational Site, Wichita Falls, Texas 63376, United States; Recruiting

Pfizer Investigational Site, Grapevine, Texas 76051, United States; Recruiting

Pfizer Investigational Site, Austin, Texas 78745, United States; Recruiting

Pfizer Investigational Site, Sugarland, Texas 77478, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77030, United States; Recruiting

Pfizer Investigational Site, Sugar Land, Texas 77479, United States; Recruiting

Pfizer Investigational Site, Lubbock, Texas 79410, United States; Recruiting

Pfizer Investigational Site, Salt Lake City, Utah 84121, United States; Recruiting

Pfizer Investigational Site, Salt Lake City, Utah 84109, United States; Recruiting

Pfizer Investigational Site, Roanoke, Virginia 24018, United States; Recruiting

Pfizer Investigational Site, Arlington, Virginia 22205, United States; Recruiting

Pfizer Investigational Site, Spokane, Washington 99204-2336, United States; Recruiting

Pfizer Investigational Site, Selah, Washington 98942, United States; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: May 2009
Ending date: June 2010
Last updated: October 7, 2009