Tanezumab In Osteoarthritis Of The Knee (2)

Condition(s) targeted: Arthritis; Osteoarthritis

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

Phase: N/A

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

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.

Official title: 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

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 the WOMAC Pain subscale

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

Criteria:

Inclusion Criteria:

- Osteoarthritis of the 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, neurologic or cardiac disease

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

Pfizer Investigational Site, Anniston, Alabama 36207, United States; Recruiting

Pfizer Investigational Site, Phoenix, Arizona 85023, United States; Recruiting

Pfizer Investigational Site, Peoria, Arizona 85381, United States; Recruiting

Pfizer Investigational Site, Paradise Valley, Arizona 85253, United States; Recruiting

Pfizer Investigational Site, Tuscon, Arizona 85724, United States; Recruiting

Pfizer Investigational Site, Hot Springs, Arkansas 71913, United States; Recruiting

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

Pfizer Investigational Site, Huntington Beach, California 92646, United States; Recruiting

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

Pfizer Investigational Site, Beverly Hills, California 90211, United States; Recruiting

Pfizer Investigational Site, Stamford, Connecticut 06905, United States; Recruiting

Pfizer Investigational Site, Newark, Delaware 19713, United States; Recruiting

Pfizer Investigational Site, Tamarac, Florida 33321, United States; Recruiting

Pfizer Investigational Site, Clearwater, Florida 33761, United States; Recruiting

Pfizer Investigational Site, DeLand, Florida 32720, United States; Recruiting

Pfizer Investigational Site, Palm Harbor, Florida 34684, United States; Recruiting

Pfizer Investigational Site, West Palm Beach, Florida 33409, United States; Recruiting

Pfizer Investigational Site, Pembroke Pines, Florida 33024, United States; Recruiting

Pfizer Investigational Site, Coral Gables, Florida 33134, United States; Recruiting

Pfizer Investigational Site, Jacksonville, Florida 32205, United States; Recruiting

Pfizer Investigational Site, Longwood, Florida 32779, United States; Recruiting

Pfizer Investigational Site, Clearwater, Florida 33756, United States; Recruiting

Pfizer Investigational Site, Port Orange, Florida 32127, United States; Recruiting

Pfizer Investigational Site, Marietta, Georgia 30060, United States; Recruiting

Pfizer Investigational Site, Decatur, Georgia 30333, United States; Recruiting

Pfizer Investigational Site, Atlanta, Georgia 30342, United States; Recruiting

Pfizer Investigational Site, Woodstock, Georgia 30189, United States; Recruiting

Pfizer Investigational Site, Boise, Idaho 83702, United States; Recruiting

Pfizer Investigational Site, Morton Grove, Illinois 60053, United States; Recruiting

Pfizer Investigational Site, Morton, Illinois 61550, United States; Recruiting

Pfizer Investigational Site, Springfield, Illinois 62704, United States; Recruiting

Pfizer Investigational Site, Chicago, Illinois 60611-4542, United States; Recruiting

Pfizer Investigational Site, Valparaiso, Indiana 46383, United States; Recruiting

Pfizer Investigational Site, Ames, Iowa 50010, United States; Recruiting

Pfizer Investigational Site, West Des Moines, Iowa 50265, United States; Recruiting

Pfizer Investigational Site, Wichita, Kansas 67203, United States; Recruiting

Pfizer Investigational Site, Louisville, Kentucky 40202, United States; Recruiting

Pfizer Investigational Site, Auburn, Maine 04210, United States; Recruiting

Pfizer Investigational Site, Wheaton, Maryland 20902, United States; Recruiting

Pfizer Investigational Site, Frederick, Maryland 21702, United States; Recruiting

Pfizer Investigational Site, Worcester, Massachusetts 01610, United States; Recruiting

Pfizer Investigational Site, St. Clair Shores, Michigan 48081, United States; Recruiting

Pfizer Investigational Site, Edina, Minnesota 55435, United States; Recruiting

Pfizer Investigational Site, St. Louis, Missouri 63141, United States; Recruiting

Pfizer Investigational Site, Omaha, Nebraska 68114, United States; Recruiting

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

Pfizer Investigational Site, Las Vegas, Nevada 89128, United States; Recruiting

Pfizer Investigational Site, Berlin, New Jersey 08009, United States; Recruiting

Pfizer Investigational Site, Albuquerque, New Mexico 87106, United States; Recruiting

Pfizer Investigational Site, Albuquerque, New Mexico 87102, United States; Recruiting

Pfizer Investigational Site, New York, New York 10024, United States; Recruiting

Pfizer Investigational Site, Rochester, New York 14618, United States; Recruiting

Pfizer Investigational Site, Roslyn, New York 11576, United States; Recruiting

Pfizer Investigational Site, Charlotte, North Carolina 28210, United States; Recruiting

Pfizer Investigational Site, Greensboro, North Carolina 27408, United States; Recruiting

Pfizer Investigational Site, Fargo, North Dakota 58104, United States; Recruiting

Pfizer Investigational Site, Middleburg Heights, Ohio 44130, United States; Recruiting

Pfizer Investigational Site, Cincinnati, Ohio 45224, United States; Recruiting

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

Pfizer Investigational Site, Oklahoma City, Oklahoma 73109, United States; Recruiting

Pfizer Investigational Site, West Reading, Pennsylvania 19611-1124, United States; Recruiting

Pfizer Investigational Site, Duncansville, Pennsylvania 16635-0909, United States; Recruiting

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

Pfizer Investigational Site, Rapid City, South Dakota 57702, United States; Recruiting

Pfizer Investigational Site, Johnson City, Tennessee 37604-1417, United States; Recruiting

Pfizer Investigational Site, Kingsport, Tennessee 37660, United States; Terminated

Pfizer Investigational Site, Dallas, Texas 75230, United States; Recruiting

Pfizer Investigational Site, San Antonio, Texas 78229, United States; Recruiting

Pfizer Investigational Site, Austin, Texas 78705, United States; Recruiting

Pfizer Investigational Site, San Antonio, Texas 78217, United States; Recruiting

Pfizer Investigational Site, Houston, Texas 77008, United States; Recruiting

Pfizer Investigational Site, Orem, Utah 84058, United States; Recruiting

Pfizer Investigational Site, Norfolk, Virginia 23502, United States; Recruiting

Pfizer Investigational Site, Portsmouth, Virginia 23701, United States; Recruiting

Pfizer Investigational Site, Yakima, Washington 98902, United States; Recruiting

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

Starting date: May 2009
Ending date: May 2010
Last updated: October 9, 2009