CHRONIC LOW BACK PAIN MedDRA version: 18.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859
Conditions
Sponsors
Pfizer Inc, 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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. Refer to protocol for full list of inclusion criteria Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1530 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 270
Exclusion criteria
Exclusion criteria: -Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria. Subjects who have Kellgren Lawrence Grade =2 radiographic evidence of hip or Grade =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. Please refer to the protocol for the remaining exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -Evaluate the long-term safety of tanezumab 10 mg and 5 mg SC administered every 8 weeks (7 administrations); -Estimate the long-term analgesic efficacy of tanezumab 10 mg and 5 mg SC administered every 8 weeks (7 administrations) up to Week 56; - Compare the analgesic efficacy of tanezumab 10 mg SC administered every 8 weeks relative to an active comparator (oral tramadol PR) at Week 16. ;Main Objective: Demonstrate superior analgesic efficacy of tanezumab 10 mg and 5 mg administered subcutaneously (SC) every 8 weeks compared to placebo at Week 16.;Primary end point(s): Change from Baseline to Week 16 in the daily average Low Back Pain Intensity (LBPI) score as measured by an 11-point Numeric Rating Scale for tanezumab vs placebo.;Timepoint(s) of evaluation of this end point: Please refer to the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Key Secondary Endpoints: -Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire(RMDQ) for tanezumab vs placebo; -Change from Baseline to Week 16 in the daily average LBPI score as measured by an 11-point Numeric Rating Scale for tanezumab vs. tramadol PR. ;Timepoint(s) of evaluation of this end point: Please refer to the protocol | — |
Countries
Canada, Denmark, France, Hungary, Japan, Korea, Republic of, Spain, Sweden, United States
Contacts
Public ContactClinicalTrials.gov call Center
Pfizer Inc
Outcome results
None listed