Clinical trial NCT02528253: A Phase 3 Study of Tanezumab for Chronic Low Back Pain
Official title: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Chronic low back pain
Chronic pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2015-08-19
Enrollment: 1832
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

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.

Primary outcomes:
measure: Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo
timeFrame: Baseline, Week 16
measure: Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
timeFrame: Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
measure: Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64
timeFrame: Baseline, Week 64
measure: Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Total Score at Weeks 2, 4, 8, 16 (for Tanezumab vs Tramadol) 24, 32, 40, 48 and 56
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 64 and 80: Observed Data
timeFrame: Baseline, Weeks 64 and 80
measure: Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Patient's Global Assessment (PGA) of Low Back Pain at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Percentage of Participants With Cumulative Percent Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Weeks 16, 24 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 16, 24 and 56
measure: Percentage of Participants Achieving Average LBPI Reduction of >=30 Percent(%), >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
measure: Percentage of Participants Achieving RMDQ Reduction of >=30%, >=50%, >=70% and >=90% From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Percentage of Participants With Cumulative Percent Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) Score at Weeks 16, 24 and 56
timeFrame: Baseline, Weeks 16, 24 and 56
measure: Change From Baseline in Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Worst Pain at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Scores Average Pain at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Average Pain at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference Index at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With General Activity at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Walking Ability at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Sleep at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Observed Data
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Score Pain Interference With Normal Work at Week 64: Observed Data
timeFrame: Baseline, Week 64
measure: Number of Participants Who Responded for Chronic Low Back Pain Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Low Back Pain From Baseline at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56: Mixed Baseline Observation Carried Forward (BOCF)/ Last Observation CF (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
measure: European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score
timeFrame: Baseline, Weeks 8, 16, 24, 40 and 56
measure: European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value
timeFrame: Baseline, Weeks 8, 16, 24, 40, 56 and 64
measure: Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Baseline: Observed Data
timeFrame: Baseline
measure: Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Low Back Pain (WPAI:LBP) Scores at Weeks 16, 56 and 64
timeFrame: Baseline, Weeks 16, 56 and 64
measure: Number of Participants Who Withdrew Due to Lack of Efficacy
timeFrame: Baseline up to Week 56
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 56
measure: Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 56 and 64
measure: Number of Participants Who Took Rescue Medication During Week 64: Observed Data
timeFrame: Week 64
measure: Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
timeFrame: Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48 and 56
measure: Number of Days of Rescue Medication Used at Week 64
timeFrame: Week 64
measure: Amount of Rescue Medication Used at Weeks 2, 4, 8, 12 and 16
timeFrame: Weeks 2, 4, 8, 12 and 16
measure: Health Care Resource Utilization (HCRU): Number of Visits of Services Received Directly Related to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Low Back Pain
timeFrame: Baseline, Weeks 64 and 80
measure: Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) at Weeks 16 and 56
timeFrame: Weeks 16 and 56
measure: Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Low Back Pain Before Enrolling?
timeFrame: Weeks 16 and 56
measure: Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer The Drug That You Received in This Study to Previous Treatment?
timeFrame: Weeks 16 and 56
measure: Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use The Same Drug That You Have Received in This Study For Your Low Back Pain Pain?
timeFrame: Weeks 16 and 56
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 80
measure: Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 56
timeFrame: Baseline up to Week 56
measure: Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
timeFrame: Baseline up to Week 80
measure: Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
timeFrame: Baseline up to Week 80
measure: Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
measure: Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
measure: Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 16, 56 and 80
timeFrame: Baseline, Weeks 16, 56 and 80
measure: Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 16, 56 and 80
timeFrame: Baseline, Weeks 16, 56 and 80
measure: Number of Participants With Confirmed Orthostatic Hypotension
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
measure: Change From Screening in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
timeFrame: Screening (up to maximum of 37 days prior to Baseline), Weeks 24, 56 and 80
measure: Percentage of Participants With Adjudicated Joint Safety Outcomes
timeFrame: Baseline up to Week 80
measure: Percentage of Participants With Total Joint Replacements
timeFrame: Baseline up to Week 80
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
measure: Number of Participants With Anti Tanezumab Antibodies
timeFrame: Baseline, Weeks 8, 16, 32, 40, 48, 56, 64 and 80
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Birmingham
country: United States
facility: Cahaba Research
state: Alabama
city: Mobile
country: United States
facility: Alabama Clinical Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Alabama Orthopaedic Clinic, P.C.
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Partners, LLC
state: Alabama
city: Saraland
country: United States
facility: The Center for Clinical Trials, Inc.
state: Alabama
city: Mesa
country: United States
facility: Ferguson Family Medicine
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Valley Pain Consultants
state: Arizona
city: Little Rock
country: United States
facility: KLR Business Group dba Arkansas Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: Primary Care of Arkansas, P.A.
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: El Cajon
country: United States
facility: Triwest Research Associates, LLC
state: California
city: Fresno
country: United States
facility: Research Center of Fresno, Inc.
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Fresno
country: United States
facility: Valley Research-Trials
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC.
state: California
city: La Mesa
country: United States
facility: eStudySite
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC.
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: USC IDS Pharmacy
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Valley Village
country: United States
facility: Bayview Research Group
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc.
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Milford
country: United States
facility: My Health 1st Urgent Care
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research,LLC
state: Florida
city: DeLand
country: United States
facility: Midland Florida Clinical Research Center, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: S&W Clinical Research
state: Florida
city: Hallandale Beach
country: United States
facility: MD Clinical
state: Florida
city: Hollywood
country: United States
facility: Pines Clinical Research Inc.
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research, LLC
state: Florida
city: Miami
country: United States
facility: Columbus Clinical Services, LLC
state: Florida
city: Miami
country: United States
facility: Larkin Imaging Center
state: Florida
city: Miami
country: United States
facility: M & M Medical Center, Inc
state: Florida
city: Miami
country: United States
facility: Quality Research & Medical Center LLC
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare, LLC.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Orlando
country: United States
facility: National Pain Research Institute
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Sarasota
country: United States
facility: Gulfcoast Research Institute
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Gainesville
country: United States
facility: Center for Advanced Research & Education
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Marietta
country: United States
facility: Non-Surgical Orthopaedics, P.C.
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research Inc
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: Southeast Regional Research Group
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Internal Medicine
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Chicago
country: United States
facility: Medex Healthcare Research Inc
state: Illinois
city: Chicago
country: United States
facility: Chicago Clinical Research Institute, Inc.
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine, Lavin Pavilion
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Chicago
country: United States
facility: Chicago Anesthesia Pain Specialists
state: Illinois
city: Skokie
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Brownsburg
country: United States
facility: Investigators Research Group, LLC
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Lafayette
country: United States
facility: Lafayette Clinical Research Group
state: Indiana
city: Lafayette
country: United States
facility: Lafayette Regional Vein and Laser Center
state: Indiana
city: Valparaiso
country: United States
facility: Buynak Clinical Research, P.C.
state: Indiana
city: Des Moines
country: United States
facility: The Iowa Clinic - Internal Medicine
state: Iowa
city: Des Moines
country: United States
facility: The Iowa Clinic Medical Imaging
state: Iowa
city: Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic Medical Imaging
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic
state: Iowa
city: Overland Park
country: United States
facility: Mid-America Physiatrists, P.A.
state: Kansas
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Crestview Hills
country: United States
facility: Mayfield Imaging Center
state: Kentucky
city: Edgewood
country: United States
facility: Otri-Med Corporation
state: Kentucky
city: Edgewood
country: United States
facility: St Elizabeth Hospital Edgewood
state: Kentucky
city: Bossier City
country: United States
facility: Willis-Knighton Physician Network/ Spine and Pain Specialist
state: Louisiana
city: Bossier City
country: United States
facility: Willis-Knighton Physician Network/WKB Family Medicine Associates
state: Louisiana
city: Lake Charles
country: United States
facility: Centex Studies, Inc
state: Louisiana
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: New Orleans
country: United States
facility: George Stanley Walker, MD
state: Louisiana
city: Cumberland
country: United States
facility: Klein & Associates, M.D., P.A.
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Rochester Hills
country: United States
facility: Michigan Orthopaedic Spine Surgeons
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research
state: Michigan
city: Wyoming
country: United States
facility: Michigan Pain Consultants
state: Michigan
city: Jackson
country: United States
facility: CRC of Jackson, LLC
state: Mississippi
city: Jackson
country: United States
facility: Physician's Surgery Center
state: Mississippi
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Omaha
country: United States
facility: Heartland Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Affiliated Clinical Research, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Office of Stephen H. Miller, MD
state: Nevada
city: Las Vegas
country: United States
facility: Office of Robert Kaplan, DO
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, Inc.
state: New Hampshire
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Marlton
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Somerset
country: United States
facility: University Clinical Research Center
state: New Jersey
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Inc.
state: New Mexico
city: Brooklyn
country: United States
facility: Healthwise Medical Associates
state: New York
city: Hartsdale
country: United States
facility: Drug Trials America
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Lenoir
country: United States
facility: Northstate Clinical Research
state: North Carolina
city: Mooresville
country: United States
facility: On Site Clinical Solutions, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC
state: North Dakota
city: Frgi
country: United States
facility: Heartland Diagnostics
state: North Dakota
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Research/Valley Medical Primary Care
state: Ohio
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Optimed Research LTD
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Medical Research, LLC
state: Ohio
city: Mentor
country: United States
facility: Oaktree Clinic
state: Ohio
city: Toledo
country: United States
facility: Bone Joint & Spine Surgeons, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: COR Clinical Research, L.L.C
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: NPC Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Columbia
country: United States
facility: TLM Medical Services
state: South Carolina
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research
state: South Carolina
city: North Charleston
country: United States
facility: Lowcountry Orthopaedics & Sports Medicine
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Knoxville
country: United States
facility: PCET Research Center, LLC
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Arlington
country: United States
facility: KRK Medical Research
state: Texas
city: Houston
country: United States
facility: Advances In Health
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc./Clear Lake Family Physicians
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Plano
country: United States
facility: The Pain Relief Center
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Lee Medical Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Draper
country: United States
facility: Physicians Research Options, LLC
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center, LLC
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
city: Bellevue
country: United States
facility: Washington Center for Pain Management
state: Washington
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Sarnia
country: Canada
facility: London Road Diagnostic Clinic & Medical Centre
state: Ontario
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
city: Quebec
country: Canada
facility: Centre de recherche Saint-Louis
city: Hillerod
country: Denmark
facility: A2 reumatologi og idraesmedicin ApS
city: Paris Cedex 14
country: France
facility: Hopital Cochin
city: Bekescsaba
country: Hungary
facility: Bekes Megyei Koezponti Korhaz Dr Rethy Pal Tagkorhaz
city: Budapest
country: Hungary
facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Ktf.
city: Kecskemét
country: Hungary
facility: Jutrix Kft.
city: Miskolc
country: Hungary
facility: CRU Hungary Ltd., MISEK HOSPITAL
city: Miskolc
country: Hungary
facility: CRU Hungary Ltd., MISEK-Radiology Department
city: Szekszard
country: Hungary
facility: Clinfan Kft.
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Showa-ku, Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Chuo-ku, Chiba
country: Japan
facility: Chiba University Hospital
state: Chiba
city: Funabashi
country: Japan
facility: Funabashi Municipal Medical Center
state: Chiba
city: Ichihara
country: Japan
facility: Chiba Rosai Hospital
state: Chiba
city: Wakaba-ku, Chiba
country: Japan
facility: Chiba Central Medical Center
state: Chiba
city: Higashi-ku,Fukuoka
country: Japan
facility: Fukuoka Mirai Hospital
state: Fukuoka
city: Kokuraminami-ku,Kitakyushu
country: Japan
facility: Kyushu Rosai Hospital
state: Fukuoka
city: Okawa
country: Japan
facility: Takagi Hospital
state: Fukuoka
city: Aizuwakamatsu
country: Japan
facility: Fukushima Medical University Aizu Medical Center
state: Fukushima
city: Hakodate
country: Japan
facility: Hakodate Central General Hospital
state: Hokkaido
city: Hakodate
country: Japan
facility: Hakodate Ohmura Orthopedic Hospital
state: Hokkaido
city: Higashinada-ku, Kobe
country: Japan
facility: Kobe Konan Yamate Clinic
state: Hyogo
city: Himeji
country: Japan
facility: Omuro Orthopedic Clinic
state: Hyogo
city: Kako-gun
country: Japan
facility: Medical corporate corporation hoshikai Onishi medical clinic
state: Hyogo
city: Kobe
country: Japan
facility: Kobe Red Cross Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center
state: Ishikawa
city: Komatsu
country: Japan
facility: Morita Hospital
state: Ishikawa
city: Matsumoto
country: Japan
facility: Marunouchi Hospital
state: Nagano
city: Beppu
country: Japan
facility: National Hospital Organization Beppu Medical Center
state: Oita
city: Higashiosaka
country: Japan
facility: Sobajima Clinic
state: Osaka
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Suminoe-ku, Osaka
country: Japan
facility: Minamiosaka Hospital
state: Osaka
city: Kumagaya
country: Japan
facility: Saitama Jikei Hospital
state: Saitama
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine, University Hospital
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical and Dental University Medical Hospital
state: Tokyo
city: Fussa
country: Japan
facility: Fussa Hospital
state: Tokyo
city: Minato-ku
country: Japan
facility: Tokyo Saiseikai Central Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Ohimachi Orthopaedic Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Yonezawa
country: Japan
facility: Yonezawa City Hospital
state: Yamagata
city: Shimonoseki-shi
country: Japan
facility: Shimonoseki City Hospital
state: Yamaguchi
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Chihaya Hospital
city: Fukuoka
country: Japan
facility: Kuroda Orthopedic Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
city: Saitama
country: Japan
facility: Saitama Municipal Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Seoul
country: Korea, Republic of
facility: CTC Pharmacy, Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: CTC Pharmacy, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Pharmacy, Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Santiago de Compostela
country: Spain
facility: Hospital Nuestra Senora de la Esperanza
state: A Coruna
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Alicante
country: Spain
facility: Instituto de Ciencias Medicas
city: Barcelona
country: Spain
facility: Hospital de Mar Servicio de Radiologia
city: Barcelona
country: Spain
facility: Hospital del Mar Servicio de Farmacia
city: Barcelona
country: Spain
facility: Specialist, S.L.
city: Barcelona
country: Spain
facility: Specialist. Farmacia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Quiron-Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitario Quiron-Dexeus. Servicio de Farmacia
city: Barcelona
country: Spain
facility: Hospital Sanitas CIMA
city: Madrid
country: Spain
facility: Hospital Universitario La Paz.
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital La Moraleja. Pharmacy Service
city: Madrid
country: Spain
facility: Hospital La Moraleja
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Malaga
country: Spain
facility: Hospital Regional Universitario del Malaga
city: Gothenburg
country: Sweden
facility: CTC (Clinical Trial Center) Sahlgrenska University Hospital
city: Helsingborg
country: Sweden
facility: Pharmasite
city: Malmo
country: Sweden
facility: Pharmasite
city: Stockholm
country: Sweden
facility: ProbarE i Stockholm AB
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Markman JD, Schnitzer TJ, Perrot S, Beydoun SR, Ohtori S, Viktrup L, Yang R, Bramson C, West CR, Verburg KM. Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial. Pain Ther. 2022 Dec;11(4):1267-1285. doi: 10.1007/s40122-022-00424-7. Epub 2022 Aug 13.
citation: Markman JD, Bolash RB, McAlindon TE, Kivitz AJ, Pombo-Suarez M, Ohtori S, Roemer FW, Li DJ, Viktrup L, Bramson C, West CR, Verburg KM. Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety. Pain. 2020 Sep 1;161(9):2068-2078. doi: 10.1097/j.pain.0000000000001928.