Tanezumab and Nerve Function In Arthritis Patients

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.

Key facts

Study ID

NCT00863772

Run by

Pfizer

People needed

220

Starts

2009-05-18

Expected to finish

2010-11-16

Last updated by the study team

2021-02-04

Who can join

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

You may qualify if…

• BMI less or equal to 39 kg/m2
• Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
• Willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
• Patients must consent in writing to participate in the study.

You may not qualify if…

• Untreated, uncontrolled diseases,
• Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
• Significant cardiac disease within the past 6 months
• Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening
• Known bleeding disorder or anticoagulation therapy
• Planned surgery during the study period
• History of alcoholism or drug abuse in the past 2 years
• Unable to use acetaminophen
• Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
• Allergic reaction to a biologic or an antibody in the past
• Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
• Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
• Medical condition that may interfere with study endpoints or safety of the subject as determined by the investigator.

Where it is running

• JDP Medical Research, LLC — Aurora, Colorado, United States
• Alpine Neurology — Centennial, Colorado, United States
• Peak Anesthesia — Centennial, Colorado, United States
• JEM Research, LLC — Atlantis, Florida, United States
• Medical Specialists of the Palm Beaches — Atlantis, Florida, United States
• Bradenton Research Center, Inc — Bradenton, Florida, United States
• Manatee Internal Medicine — Bradenton, Florida, United States
• Clinical Physiology Associates — Fort Myers, Florida, United States
• Harris Bonnette, MD — Fort Myers, Florida, United States
• Sunrise Clinical Research, Inc. — Hollywood, Florida, United States
• Sunrise Clinical Research, Inc — Hollywood, Florida, United States
• Pharmax Research Clinic, Inc — Miami, Florida, United States
• International Research Associates, LLC — Miami, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• Pines Neurological Associates — Pembroke Pines, Florida, United States
• Pembroke Clinical Trials — Pembroke Pines, Florida, United States
• Pines Neurological Associates — Pembroke Pines, Florida, United States
• Advent Clinical Research Centers, Inc — Pinellas Park, Florida, United States
• Advent Clinical Research Center — Pinellas Park, Florida, United States
• Berma Research Group — Plantation, Florida, United States
• Kennedy-White Orthopaedic Center — Sarasota, Florida, United States
• Ronal Aung-Din, MD — Sarasota, Florida, United States
• Ronald Aung-Din, MD — Sarasota, Florida, United States
• Sarasota Center for Clinical Research — Sarasota, Florida, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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