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A Phase 3 Study of Tanezumab for Chronic Low Back Pain

Last updated on March 14, 2019

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Study Location
Central Alabama Research
Birmingham, Alabama, 35209 United States
Contact
877-355-1989
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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-Chronic low back pain ≥3 months in duration, Quebec Task Force in Spinal Disorders class 1
or 2, with documented history of previous inadequate treatment response to at least 3
different categories of agents commonly used and generally considered effective for the
treatment of chronic low back pain.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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--Diagnosis of osteoarthritis of the knee or hip as defined by the American College of
Rheumatology (ACR) criteria.

- Subjects who have Kellgren Lawrence Grade > or =2 radiographic evidence of hip or
Grade > or=3 radiographic evidence of knee osteoarthritis will be excluded;

- History or radiographic evidence of other diseases that could confound efficacy or
safety assessments (e.g., rheumatoid arthritis).

- History or radiographic evidence of orthopedic conditions that may increase the risk
of, or confound assessment of joint safety conditions during the study.

- Signs and symptoms of clinically significant cardiac disease within 6 months of the
study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly
controlled or untreated hypertension) as defined in the protocol or subjects with any
other cardiovascular illness that in the opinion of the Investigator would render a
subject unsuitable to participate in the study

- History, diagnosis, or signs and symptoms of clinically significant neurological
disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy)
as specified in the protocol

- Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g.,
orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Subcutaneous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes addition
Trial Procedures
Electrocardiogram (ECG)
Physical examination
Keeping a diary
Questionnaire
X-rays
Vital signs and measurements
Urine test
Blood test
NCT02528253
Pfizer
Completed
A Phase 3 Study of Tanezumab for Chronic Low Back Pain

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