Tanezumab in Osteoarthritis of the Knee

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Osteoarthritis

In brief

Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.

Key facts

Study ID

NCT00733902

Run by

Pfizer

People needed

697

Starts

2008-09-15

Expected to finish

2010-01-14

Last updated by the study team

2021-03-22

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
• Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
• Pain level and function levels as required by the protocol at Screening and Baseline.
• Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
• Must agree to the contraceptive requirements of the protocol if applicable.
• Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

You may not qualify if…

• Pregnancy or intent to become pregnant during the study
• BMI greater than 39
• other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

Where it is running

• Clinical Research Center of Connecticut — Danbury, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Javed Rheumatology Associates, Inc. — Newark, Delaware, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Tampa Bay Medical Research, Inc. — Clearwater, Florida, United States
• Avail Clinical Rearch, LLC — DeLand, Florida, United States
• Avail Clinical Research — DeLand, Florida, United States
• Arthritis Associates of South Florida, Clinical Research Center — Delray Beach, Florida, United States
• Delray Research Associates — Delray Beach, Florida, United States
• Westside Center for Clinical Research — Jacksonville, Florida, United States
• Neurorehabilitation & Diagnostic Services — Miami, Florida, United States
• Pharmax Research Clinic, LLC — Miami, Florida, United States
• South Medical Research Group — Miami, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• University Clinical Research Incorporated — Pembroke Pines, Florida, United States
• Advent Clinical Research Centers — Pinellas Park, Florida, United States
• AVIVOCLIN Clinical Services — Port Orange, Florida, United States
• Dale G. Bramlet, MD, P.L — St. Petersburg, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Laureate Clinical Reseach Group — Atlanta, Georgia, United States
• Jefrey D. Lieberman, MD, PC — Decatur, Georgia, United States
• Early Family Practice Center — Fort Valley, Georgia, United States
• North Georgia Clinical Research — Marietta, Georgia, United States
• Arizona Research Center, Inc. — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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