Tanezumab and Nerve Function In Arthritis Patients

Pfizer

Status and phase

Terminated

Phase 3

Conditions

Osteoarthritis

Treatments

Other: Placebo

Biological: tanezumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00863772

NERVE SAFETY STUDY (Other Identifier)

A4091026

Details and patient eligibility

About

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

Full description

This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Enrollment

220 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.