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A Phase 3 Study of Tanezumab ...

A Phase 3 Study of Tanezumab for Chronic Low Back Pain

Last Updated: 2020-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1832 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-18

Study Completion Date

2018-12-20

Brief Summary

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This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.

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Detailed Description

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This is a randomized, double blind, placebo and active controlled, multicenter, parallel group Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for up to 56 weeks in subjects with chronic low back pain. Approximately 1800 subjects will be randomized to 1 of 4 treatment groups in a 2:2:2:3 ratio (ie, 400 subjects per treatment group for the placebo, tanezumab 5 mg and tanezumab 10 mg treatment groups and 600 subjects in the tramadol PR treatment group). Treatment groups will include: 1.) Placebo administered SC at an 8 week interval plus placebo matching tramadol PR up to Week 16. At the Week 16 visit, subjects in this group who meet the efficacy responder criteria will be switched in a blinded fashion in a 1:1 ratio to either tanezumab 5 mg or tanezumab 10 mg administered SC at an 8 week interval plus placebo matching tramadol PR to Week 56; 2.)Tanezumab 5 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 3.) Tanezumab 10 mg SC administered at an 8 week interval plus placebo matching tramadol PR to Week 56; 4.) Oral tramadol PR plus placebo administered SC at an 8 week interval to Week 56. The study is designed with a total duration (post randomization) of up to 80 weeks and will consist of three periods: Screening (up to a maximum of 37 days; includes a Washout Period and an Initial Pain Assessment Period), a Double blind Treatment Period (comprised of a 16 week Primary Efficacy Phase and a 40 week Long Term Safety and Efficacy Phase), and a Follow up Period (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting 2 32 days), if required, and an Initial Pain Assessment Period (the 5 days prior to Randomization/Baseline). Prior to entering the study, subjects must have a documented history of previous inadequate treatment response to medications in 3 different categories of agents commonly used to treat and generally considered effective for the treatment of chronic low back pain.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo to Week 16; tanezumab 5 mg SC

Group Type PLACEBO_COMPARATOR

Placebo to Week 16; tanezumab 5mg SC

Intervention Type BIOLOGICAL

Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections

Placebo to Week 16, tanezumab 10 mg SC

Group Type PLACEBO_COMPARATOR

Placebo to Week 16, tanezumab 10 mg SC

Intervention Type BIOLOGICAL

Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections

Tanezumab 5 mg SC

Group Type EXPERIMENTAL

Tanezumab 5 mg SC

Intervention Type BIOLOGICAL

Tanezumab 5 mg SC

Tanezumab 10 mg SC

Group Type EXPERIMENTAL

Tanezumab 10 mg SC

Intervention Type BIOLOGICAL

Tanezumab 10 mg SC

Tramadol PR oral

Group Type ACTIVE_COMPARATOR

Tramadol PR oral

Intervention Type BIOLOGICAL

Tramadol PR oral

Interventions

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Placebo to Week 16; tanezumab 5mg SC

Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections

Intervention Type BIOLOGICAL

Placebo to Week 16, tanezumab 10 mg SC

Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections

Intervention Type BIOLOGICAL

Tanezumab 5 mg SC

Intervention Type BIOLOGICAL

Tanezumab 10 mg SC

Intervention Type BIOLOGICAL

Tramadol PR oral

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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 \> 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Central Alabama Research

Birmingham, Alabama, United States

Site Status

Cahaba Research

Birmingham, Alabama, United States

Site Status

Alabama Clinical Research, LLC

Mobile, Alabama, United States

Site Status

Alabama Orthopaedic Clinic, P.C.

Mobile, Alabama, United States

Site Status

Coastal Clinical Research

Mobile, Alabama, United States

Site Status

Horizon Research Partners, LLC

Mobile, Alabama, United States

Site Status

The Center for Clinical Trials, Inc.

Saraland, Alabama, United States

Site Status

Ferguson Family Medicine

Mesa, Arizona, United States

Site Status

The Pain Center of Arizona

Phoenix, Arizona, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Valley Pain Consultants

Scottsdale, Arizona, United States

Site Status

KLR Business Group dba Arkansas Clinical Research

Little Rock, Arkansas, United States

Site Status

Lynn Institute of the Ozarks

Little Rock, Arkansas, United States

Site Status

Primary Care of Arkansas, P.A.

Little Rock, Arkansas, United States

Site Status

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Core Healthcare Group

Cerritos, California, United States

Site Status

eStudySite

Chula Vista, California, United States

Site Status

Triwest Research Associates, LLC

El Cajon, California, United States

Site Status

Research Center of Fresno, Inc.

Fresno, California, United States

Site Status

Neuro-Pain Medical Center

Fresno, California, United States

Site Status

Valley Research-Trials

Fresno, California, United States

Site Status

Collaborative Neuroscience Network, LLC.

Garden Grove, California, United States

Site Status

eStudySite

La Mesa, California, United States

Site Status

Collaborative Neuroscience Network, LLC.

Long Beach, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

USC IDS Pharmacy

Los Angeles, California, United States

Site Status

Catalina Research Institute, LLC

Montclair, California, United States

Site Status

Providence Clinical Research

North Hollywood, California, United States

Site Status

Northern California Research

Sacramento, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

Encompass Clinical Research

Spring Valley, California, United States

Site Status

Bayview Research Group

Valley Village, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Elite Clinical Trials, Inc.

Wildomar, California, United States

Site Status

Alpine Clinical Research Center

Boulder, Colorado, United States

Site Status

Mountain View Clinical Research, Inc.

Denver, Colorado, United States

Site Status

Mountain View Clinical Research, Inc

Denver, Colorado, United States

Site Status

New England Research Associates, LLC

Bridgeport, Connecticut, United States

Site Status

My Health 1st Urgent Care

Milford, Connecticut, United States

Site Status

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Site Status

JEM Research Institute

Atlantis, Florida, United States

Site Status

Orthopedic Research Institute

Boynton Beach, Florida, United States

Site Status

Clinical Research of South Florida

Coral Gables, Florida, United States

Site Status

Avail Clinical Research,LLC

DeLand, Florida, United States

Site Status

Midland Florida Clinical Research Center, LLC

DeLand, Florida, United States

Site Status

S&W Clinical Research

Fort Lauderdale, Florida, United States

Site Status

MD Clinical

Hallandale, Florida, United States

Site Status

Pines Clinical Research Inc.

Hollywood, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Site Status

Health Awareness, Inc.

Jupiter, Florida, United States

Site Status

Columbus Clinical Services, LLC

Miami, Florida, United States

Site Status

Larkin Imaging Center

Miami, Florida, United States

Site Status

M & M Medical Center, Inc

Miami, Florida, United States

Site Status

Quality Research & Medical Center LLC

Miami, Florida, United States

Site Status

Crystal Biomedical Research, LLC

Miami Lakes, Florida, United States

Site Status

Sensible Healthcare, LLC.

Ocoee, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

National Pain Research Institute

Orlando, Florida, United States

Site Status

Progressive Medical Research

Port Orange, Florida, United States

Site Status

Gulfcoast Research Institute

Sarasota, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

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Meridien Research

Tampa, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

River Birch Research Alliance, LLC

Blue Ridge, Georgia, United States

Site Status

Columbus Regional Research Institute

Columbus, Georgia, United States

Site Status

Center for Advanced Research & Education

Gainesville, Georgia, United States

Site Status

Drug Studies America

Marietta, Georgia, United States

Site Status

Georgia Institute for Clinical Research, LLC

Marietta, Georgia, United States

Site Status

Non-Surgical Orthopaedics, P.C.

Marietta, Georgia, United States

Site Status

Better Health Clinical Research Inc

Newnan, Georgia, United States

Site Status

Better Health Clinical Research, Inc.

Newnan, Georgia, United States

Site Status

Southeast Regional Research Group

Savannah, Georgia, United States

Site Status

North Georgia Clinical Research

Woodstock, Georgia, United States

Site Status

North Georgia Internal Medicine

Woodstock, Georgia, United States

Site Status