A Phase 3 Study of Tanezumab for Chronic Low Back Pain
TANGO
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
4 other identifiers
interventional
1,832
9 countries
262
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 low-back-pain
Started Aug 2015
Longer than P75 for phase_3 low-back-pain
262 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2015
CompletedStudy Start
First participant enrolled
August 18, 2015
CompletedFirst Posted
Study publicly available on registry
August 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedResults Posted
Study results publicly available
February 21, 2020
CompletedFebruary 21, 2020
February 1, 2020
2.2 years
August 11, 2015
December 19, 2019
February 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Placebo at Week 16
Average low back pain was assessed on an 11-point numeric rating scale (NRS) captured through an interactive response technology (IRT). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Baseline, Week 16
Secondary Outcomes (65)
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ) at Week 16 for Tanezumab Versus (Vs) Placebo
Baseline, Week 16
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score for Tanezumab Versus (Vs) Tramadol at Week 16
Baseline, Week 16
Change From Baseline in Average Low Back Pain Intensity (LBPI) Score at Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Baseline, Weeks 2, 4, 8, 12, 24, 32, 40, 48 and 56
Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 64
Baseline, Week 64
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
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
- +60 more secondary outcomes
Study Arms (5)
Placebo to Week 16; tanezumab 5 mg SC
PLACEBO COMPARATORPlacebo to Week 16, tanezumab 10 mg SC
PLACEBO COMPARATORTanezumab 5 mg SC
EXPERIMENTALTanezumab 10 mg SC
EXPERIMENTALTramadol PR oral
ACTIVE COMPARATORInterventions
Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections
Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Eli Lilly and Companycollaborator
Study Sites (262)
Central Alabama Research
Birmingham, Alabama, 35209, United States
Cahaba Research
Birmingham, Alabama, 35242, United States
Alabama Clinical Research, LLC
Mobile, Alabama, 36608, United States
Alabama Orthopaedic Clinic, P.C.
Mobile, Alabama, 36608, United States
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Horizon Research Partners, LLC
Mobile, Alabama, 36608, United States
The Center for Clinical Trials, Inc.
Saraland, Alabama, 36571, United States
Ferguson Family Medicine
Mesa, Arizona, 85215, United States
The Pain Center of Arizona
Phoenix, Arizona, 85018, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
Valley Pain Consultants
Scottsdale, Arizona, 85254, United States
KLR Business Group dba Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Primary Care of Arkansas, P.A.
Little Rock, Arkansas, 72205, United States
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Core Healthcare Group
Cerritos, California, 90703, United States
eStudySite
Chula Vista, California, 91911, United States
Triwest Research Associates, LLC
El Cajon, California, 92020, United States
Research Center of Fresno, Inc.
Fresno, California, 93702, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Valley Research-Trials
Fresno, California, 93720, United States
Collaborative Neuroscience Network, LLC.
Garden Grove, California, 92845, United States
eStudySite
La Mesa, California, 91942, United States
Collaborative Neuroscience Network, LLC.
Long Beach, California, 90806, United States
University of Southern California
Los Angeles, California, 90033, United States
USC IDS Pharmacy
Los Angeles, California, 90033, United States
Catalina Research Institute, LLC
Montclair, California, 91763, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
Northern California Research
Sacramento, California, 95821, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Bayview Research Group
Valley Village, California, 91607, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Elite Clinical Trials, Inc.
Wildomar, California, 92595, United States
Alpine Clinical Research Center
Boulder, Colorado, 80301, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209, United States
Mountain View Clinical Research, Inc
Denver, Colorado, 80209, United States
New England Research Associates, LLC
Bridgeport, Connecticut, 06606, United States
My Health 1st Urgent Care
Milford, Connecticut, 06460, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research,LLC
DeLand, Florida, 32720, United States
Midland Florida Clinical Research Center, LLC
DeLand, Florida, 32720, United States
S&W Clinical Research
Fort Lauderdale, Florida, 33306, United States
MD Clinical
Hallandale, Florida, 33009, United States
Pines Clinical Research Inc.
Hollywood, Florida, 33024, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Columbus Clinical Services, LLC
Miami, Florida, 33125, United States
Larkin Imaging Center
Miami, Florida, 33173, United States
M & M Medical Center, Inc
Miami, Florida, 33185, United States
Quality Research & Medical Center LLC
Miami, Florida, 33186, United States
Crystal Biomedical Research, LLC
Miami Lakes, Florida, 33014, United States
Sensible Healthcare, LLC.
Ocoee, Florida, 34761, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
National Pain Research Institute
Orlando, Florida, 32807, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Gulfcoast Research Institute
Sarasota, Florida, 34232, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Meridien Research
Tampa, Florida, 33634, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Center for Advanced Research & Education
Gainesville, Georgia, 30501, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060, United States
Non-Surgical Orthopaedics, P.C.
Marietta, Georgia, 30060, United States
Better Health Clinical Research Inc
Newnan, Georgia, 30265, United States
Better Health Clinical Research, Inc.
Newnan, Georgia, 30265, United States
Southeast Regional Research Group
Savannah, Georgia, 31401, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Georgia Internal Medicine
Woodstock, Georgia, 30189, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Medex Healthcare Research Inc
Chicago, Illinois, 60602, United States
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, 60607, United States
Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center
Chicago, Illinois, 60611, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Northwestern University, Feinberg School of Medicine, Lavin Pavilion
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Chicago Anesthesia Pain Specialists
Chicago, Illinois, 60657, United States
Clinical Investigation Specialists, Inc.
Skokie, Illinois, 60076, United States
Investigators Research Group, LLC
Brownsburg, Indiana, 46112, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Lafayette Clinical Research Group
Lafayette, Indiana, 47905, United States
Lafayette Regional Vein and Laser Center
Lafayette, Indiana, 47905, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, 46383, United States
The Iowa Clinic - Internal Medicine
Des Moines, Iowa, 50309, United States
The Iowa Clinic Medical Imaging
Des Moines, Iowa, 50309, United States
The Iowa Clinic
Des Moines, Iowa, 50309, United States
The Iowa Clinic Medical Imaging
West Des Moines, Iowa, 50266, United States
The Iowa Clinic
West Des Moines, Iowa, 50266, United States
Mid-America Physiatrists, P.A.
Overland Park, Kansas, 66210, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205, United States
Mayfield Imaging Center
Crestview Hills, Kentucky, 41017, United States
Otri-Med Corporation
Edgewood, Kentucky, 41017, United States
St Elizabeth Hospital Edgewood
Edgewood, Kentucky, 41017, United States
Willis-Knighton Physician Network/ Spine and Pain Specialist
Bossier City, Louisiana, 71111, United States
Willis-Knighton Physician Network/WKB Family Medicine Associates
Bossier City, Louisiana, 71111, United States
Centex Studies, Inc
Lake Charles, Louisiana, 70601, United States
Best Clinical Trials, LLC
New Orleans, Louisiana, 70115, United States
George Stanley Walker, MD
New Orleans, Louisiana, 70115, United States
Klein & Associates, M.D., P.A.
Cumberland, Maryland, 21502, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Michigan Orthopaedic Spine Surgeons
Rochester Hills, Michigan, 48307, United States
Oakland Medical Research
Troy, Michigan, 48085, United States
Michigan Pain Consultants
Wyoming, Michigan, 49519, United States
CRC of Jackson, LLC
Jackson, Mississippi, 39202, United States
Physician's Surgery Center
Jackson, Mississippi, 39202, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Heartland Clinical Research, Inc.
Omaha, Nebraska, 68134, United States
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, 89106, United States
Office of Stephen H. Miller, MD
Las Vegas, Nevada, 89117, United States
Office of Robert Kaplan, DO
Las Vegas, Nevada, 89119, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire, 03801, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
CRI Worldwide, LLC
Marlton, New Jersey, 08053, United States
University Clinical Research Center
Somerset, New Jersey, 08873, United States
Premier Research
Trenton, New Jersey, 08611, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
New Mexico Clinical Research & Osteoporosis Center, Inc.
Albuquerque, New Mexico, 87106, United States
Healthwise Medical Associates
Brooklyn, New York, 11206, United States
Drug Trials America
Hartsdale, New York, 10530, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
AAIR Research Center
Rochester, New York, 14618, United States
University of Rochester
Rochester, New York, 14618, United States
Northstate Clinical Research
Lenoir, North Carolina, 28645, United States
On Site Clinical Solutions, LLC
Mooresville, North Carolina, 28117, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
The Center for Clinical Research
Winston-Salem, North Carolina, 27103, United States
Lillestol Research, LLC
Fargo, North Dakota, 58104, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, 58104, United States
Heartland Diagnostics
Frgi, North Dakota, 58104, United States
Clinical Inquest Center Ltd
Beavercreek, Ohio, 45431, United States
Valley Medical Research/Valley Medical Primary Care
Centerville, Ohio, 45459, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Optimed Research LTD
Columbus, Ohio, 43235, United States
Prestige Clinical Research
Franklin, Ohio, 45005, United States
Great Lakes Medical Research, LLC
Mentor, Ohio, 44060, United States
Oaktree Clinic
Mentor, Ohio, 44060, United States
Bone Joint & Spine Surgeons, Inc.
Toledo, Ohio, 43623, United States
COR Clinical Research, L.L.C
Oklahoma City, Oklahoma, 73103, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
NPC Research
Oklahoma City, Oklahoma, 73109, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
TLM Medical Services
Columbia, South Carolina, 29204, United States
DeGarmo Institute of Medical Research
Greer, South Carolina, 29650, United States
Lowcountry Orthopaedics & Sports Medicine
North Charleston, South Carolina, 29406, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
PCET Research Center, LLC
Knoxville, Tennessee, 37909, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
KRK Medical Research
Arlington, Texas, 76012, United States
Advances In Health
Houston, Texas, 77030, United States
Centex Studies, Inc./Clear Lake Family Physicians
Houston, Texas, 77058, United States
Clinical Trial Network
Houston, Texas, 77074, United States
The Pain Relief Center
Plano, Texas, 75024, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
Lee Medical Associates, PA
San Antonio, Texas, 78213, United States
Progressive Clinical Research, PA
San Antonio, Texas, 78213, United States
Physicians Research Options, LLC
Draper, Utah, 84020, United States
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, 22911, United States
Virginia Research Center
Midlothian, Virginia, 23114, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294, United States
Washington Center for Pain Management
Bellevue, Washington, 98004, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
SKDS Research Inc.
Newmarket, Ontario, L3Y 5G8, Canada
London Road Diagnostic Clinic & Medical Centre
Sarnia, Ontario, N7T 4X3, Canada
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, Quebec, G1V 3M7, Canada
Centre de recherche Saint-Louis
Québec, Quebec, G1W 4R4, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8, Canada
A2 reumatologi og idraesmedicin ApS
Hillerød, 3400, Denmark
Hopital Cochin
Paris, 75679, France
Bekes Megyei Koezponti Korhaz Dr Rethy Pal Tagkorhaz
Békéscsaba, 5600, Hungary
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
Budapest, 1033, Hungary
Obudai Egeszsegugyi Centrum Ktf.
Budapest, 1036, Hungary
Jutrix Kft.
Kecskemét, 6000, Hungary
CRU Hungary Ltd., MISEK HOSPITAL
Miskolc, 3529, Hungary
CRU Hungary Ltd., MISEK-Radiology Department
Miskolc, 3529, Hungary
Clinfan Kft.
Szekszárd, 7100, Hungary
Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly
Szekszárd, 7100, Hungary
Aichi Medical University Hospital
Nagakute, Aichi-ken, 480-1195, Japan
Nagoya University Hospital
Showa-ku, Nagoya, Aichi-ken, 466-8560, Japan
Chiba University Hospital
Chuo-ku, Chiba, Chiba, 260-8677, Japan
Funabashi Municipal Medical Center
Funabashi, Chiba, 273-8588, Japan
Chiba Rosai Hospital
Ichihara, Chiba, 290-0003, Japan
Chiba Central Medical Center
Wakaba-ku, Chiba, Chiba, 264-0017, Japan
Fukuoka Mirai Hospital
Higashi-ku,Fukuoka, Fukuoka, 813-0017, Japan
Kyushu Rosai Hospital
Kokuraminami-ku,Kitakyushu, Fukuoka, 800-0296, Japan
Takagi Hospital
Ōkawa, Fukuoka, 831-0016, Japan
Fukushima Medical University Aizu Medical Center
Aizu-Wakamatsu, Fukushima, 969-3492, Japan
Hakodate Central General Hospital
Hakodate, Hokkaido, 040-8585, Japan
Hakodate Ohmura Orthopedic Hospital
Hakodate, Hokkaido, 041-0802, Japan
Kobe Konan Yamate Clinic
Higashinada-ku, Kobe, Hyōgo, 658-0011, Japan
Omuro Orthopedic Clinic
Himeji, Hyōgo, 670-0976, Japan
Medical corporate corporation hoshikai Onishi medical clinic
Kako-gun, Hyōgo, 675-1115, Japan
Kobe Red Cross Hospital
Kobe, Hyōgo, 651-0073, Japan
National Hospital Organization Kanazawa Medical Center
Kanazawa, Ishikawa-ken, 920-8650, Japan
Morita Hospital
Komatsu, Ishikawa-ken, 923-8507, Japan
Marunouchi Hospital
Matsumoto, Nagano, 390-8601, Japan
National Hospital Organization Beppu Medical Center
Beppu, Oita Prefecture, 874-0011, Japan
Sobajima Clinic
Higashiosaka, Osaka, 577-0011, Japan
Rinku General Medical Center
Izumisano, Osaka, 598-8577, Japan
Minamiosaka Hospital
Suminoe-ku, Osaka, Osaka, 559-0012, Japan
Saitama Jikei Hospital
Kumagaya, Saitama, 360-0816, Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, 431-3192, Japan
Tokyo Medical and Dental University Medical Hospital
Bunkyo-ku, Tokyo, 113-8519, Japan
Fussa Hospital
Fussa, Tokyo, 197-8511, Japan
Tokyo Saiseikai Central Hospital
Minato-ku, Tokyo, 108-0073, Japan
Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
Shinagawa-ku, Tokyo, 140-0001, Japan
Ohimachi Orthopaedic Clinic
Shinagawa-ku, Tokyo, 140-0014, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Yonezawa City Hospital
Yonezawa, Yamagata, 992-8502, Japan
Shimonoseki City Hospital
Shimonoseki-shi, Yamaguchi, 750-8520, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, 755-8505, Japan
Chihaya Hospital
Fukuoka, 813-8501, Japan
Kuroda Orthopedic Hospital
Fukuoka, 814-0165, Japan
Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619, Japan
Saitama Municipal Hospital
Saitama, 336-8522, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
CTC Pharmacy, Seoul National University Hospital
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
CTC Pharmacy, Severance Hospital
Seoul, 03722, South Korea
Severance Hospital
Seoul, 03722, South Korea
Clinical Trial Pharmacy, Samsung Medical Center
Seoul, 06351, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Nuestra Senora de la Esperanza
Santiago de Compostela, A Coruna, 15705, Spain
Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia
A Coruña, 15006, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Instituto de Ciencias Medicas
Alicante, 03004, Spain
Hospital de Mar Servicio de Radiologia
Barcelona, 08003, Spain
Hospital del Mar Servicio de Farmacia
Barcelona, 08003, Spain
Specialist, S.L.
Barcelona, 08006, Spain
Specialist. Farmacia
Barcelona, 08006, Spain
Hospital del Mar
Barcelona, 08024, Spain
Hospital Universitario Quiron-Dexeus
Barcelona, 08025, Spain
Hospital Universitario Quiron-Dexeus. Servicio de Farmacia
Barcelona, 08028, Spain
Hospital Sanitas CIMA
Barcelona, 08034, Spain
Hospital Universitario La Paz.
Madrid, 28046, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital La Moraleja. Pharmacy Service
Madrid, 28050, Spain
Hospital La Moraleja
Madrid, 28050, Spain
Hospital Regional Universitario de Malaga
Málaga, 29009, Spain
Hospital Regional Universitario del Malaga
Málaga, 29009, Spain
CTC (Clinical Trial Center) Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Pharmasite
Helsingborg, 252 20, Sweden
Pharmasite
Malmo, 21152, Sweden
ProbarE i Stockholm AB
Stockholm, 111 37, Sweden
Related Publications (2)
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.
PMID: 35962939DERIVEDMarkman 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.
PMID: 32453139DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2015
First Posted
August 19, 2015
Study Start
August 18, 2015
Primary Completion
October 17, 2017
Study Completion
December 20, 2018
Last Updated
February 21, 2020
Results First Posted
February 21, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.