A Phase 3 Study of Tanezumab for Chronic Low Back Pain

PHASE3CompletedINTERVENTIONAL
Enrollment

1,832

Participants

Timeline

Start Date

August 18, 2015

Primary Completion Date

October 17, 2017

Study Completion Date

December 20, 2018

Conditions
Low Back Pain
Interventions
BIOLOGICAL

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

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

BIOLOGICAL

Tanezumab 5 mg SC

Tanezumab 5 mg SC

BIOLOGICAL

Tanezumab 10 mg SC

Tanezumab 10 mg SC

BIOLOGICAL

Tramadol PR oral

Tramadol PR oral

Trial Locations (262)

1033

Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft., Budapest

1036

Obudai Egeszsegugyi Centrum Ktf., Budapest

3400

A2 reumatologi og idraesmedicin ApS, Hillerød

3529

CRU Hungary Ltd., MISEK HOSPITAL, Miskolc

CRU Hungary Ltd., MISEK-Radiology Department, Miskolc

5600

Bekes Megyei Koezponti Korhaz Dr Rethy Pal Tagkorhaz, Békéscsaba

6000

Jutrix Kft., Kecskemét

7100

Clinfan Kft., Szekszárd

Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly, Szekszárd

10128

The Medical Research Network, LLC, New York

10530

Drug Trials America, Hartsdale

11206

Healthwise Medical Associates, Brooklyn

14618

AAIR Research Center, Rochester

University of Rochester, Rochester

15006

Complejo Hospitalario Universitario A Coruna. Servicio de Farmacia, A Coruña

Complejo Hospitalario Universitario A Coruña, A Coruña

15705

Hospital Nuestra Senora de la Esperanza, Santiago de Compostela

16635

Altoona Center for Clinical Research, Duncansville

19335

Brandywine Clinical Research, Downingtown

20902

The Center for Rheumatology and Bone Research, Wheaton

21152

Pharmasite, Malmo

21502

Klein & Associates, M.D., P.A., Cumberland

22911

Charlottesville Medical Research Center, LLC, Charlottesville

23114

Virginia Research Center, Midlothian

23294

National Clinical Research - Richmond, Inc., Richmond

27103

PMG Research of Winston-Salem, LLC, Winston-Salem

The Center for Clinical Research, Winston-Salem

27612

Wake Research Associates, LLC, Raleigh

28046

Hospital Universitario La Paz., Madrid

Hospital Universitario La Paz, Madrid

28050

Hospital La Moraleja. Pharmacy Service, Madrid

Hospital La Moraleja, Madrid

28117

On Site Clinical Solutions, LLC, Mooresville

28645

Northstate Clinical Research, Lenoir

29009

Hospital Regional Universitario de Malaga, Málaga

Hospital Regional Universitario del Malaga, Málaga

29204

TLM Medical Services, Columbia

29406

Lowcountry Orthopaedics & Sports Medicine, North Charleston

29650

DeGarmo Institute of Medical Research, Greer

30060

Drug Studies America, Marietta

Georgia Institute for Clinical Research, LLC, Marietta

Non-Surgical Orthopaedics, P.C., Marietta

30189

North Georgia Clinical Research, Woodstock

North Georgia Internal Medicine, Woodstock

30265

Better Health Clinical Research Inc, Newnan

Better Health Clinical Research, Inc., Newnan

30501

Center for Advanced Research & Education, Gainesville

30513

River Birch Research Alliance, LLC, Blue Ridge

31401

Southeast Regional Research Group, Savannah

31904

Columbus Regional Research Institute, Columbus

32127

Progressive Medical Research, Port Orange

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32720

Avail Clinical Research,LLC, DeLand

Midland Florida Clinical Research Center, LLC, DeLand

32806

Compass Research, LLC, Orlando

32807

National Pain Research Institute, Orlando

33009

MD Clinical, Hallandale

33014

Crystal Biomedical Research, LLC, Miami Lakes

33024

Pines Clinical Research Inc., Hollywood

33125

Columbus Clinical Services, LLC, Miami

33134

Clinical Research of South Florida, Coral Gables

33173

Larkin Imaging Center, Miami

33185

M & M Medical Center, Inc, Miami

33186

Quality Research & Medical Center LLC, Miami

33306

S&W Clinical Research, Fort Lauderdale

33409

Palm Beach Research Center, West Palm Beach

33458

Health Awareness, Inc., Jupiter

33462

JEM Research Institute, Atlantis

33472

Orthopedic Research Institute, Boynton Beach

33634

Meridien Research, Tampa

33709

Meridien Research, St. Petersburg

34232

Gulfcoast Research Institute, Sarasota

34761

Sensible Healthcare, LLC., Ocoee

35209

Central Alabama Research, Birmingham

35242

Cahaba Research, Birmingham

36571

The Center for Clinical Trials, Inc., Saraland

36608

Alabama Clinical Research, LLC, Mobile

Alabama Orthopaedic Clinic, P.C., Mobile

Coastal Clinical Research, Mobile

Horizon Research Partners, LLC, Mobile

37211

Quality Medical Research, Nashville

37909

PCET Research Center, LLC, Knoxville

38654

Olive Branch Family Medical Center, Olive Branch

39202

CRC of Jackson, LLC, Jackson

Physician's Surgery Center, Jackson

41017

Mayfield Imaging Center, Crestview Hills

Otri-Med Corporation, Edgewood

St Elizabeth Hospital Edgewood, Edgewood

43235

Optimed Research LTD, Columbus

43623

Bone Joint & Spine Surgeons, Inc., Toledo

44060

Great Lakes Medical Research, LLC, Mentor

Oaktree Clinic, Mentor

45005

Prestige Clinical Research, Franklin

45224

Hightop Medical Research Center, Cincinnati

45242

New Horizons Clinical Research, Cincinnati

45431

Clinical Inquest Center Ltd, Beavercreek

45459

Valley Medical Research/Valley Medical Primary Care, Centerville

46112

Investigators Research Group, LLC, Brownsburg

46383

Buynak Clinical Research, P.C., Valparaiso

47714

MediSphere Medical Research Center, LLC, Evansville

47905

Lafayette Clinical Research Group, Lafayette

Lafayette Regional Vein and Laser Center, Lafayette

48085

Oakland Medical Research, Troy

48307

Michigan Orthopaedic Spine Surgeons, Rochester Hills

48706

Great Lakes Research Group, Inc., Bay City

49519

Michigan Pain Consultants, Wyoming

50266

The Iowa Clinic Medical Imaging, West Des Moines

The Iowa Clinic, West Des Moines

50309

The Iowa Clinic - Internal Medicine, Des Moines

The Iowa Clinic Medical Imaging, Des Moines

The Iowa Clinic, Des Moines

57702

Health Concepts, Rapid City

58104

Lillestol Research, LLC, Fargo

Plains Clinical Research Center, LLC, Fargo

Heartland Diagnostics, Frgi

60076

Clinical Investigation Specialists, Inc., Skokie

60602

Medex Healthcare Research Inc, Chicago

60607

Chicago Clinical Research Institute, Inc., Chicago

60611

Northwestern Memorial Hospital - Arkes Pavilion, Diagnostic Testing Center, Chicago

Northwestern University Feinberg School of Medicine, Chicago

Northwestern University, Feinberg School of Medicine, Lavin Pavilion, Chicago

Northwestern University, Chicago

60640

Great Lakes Clinical Trials, Chicago

60657

Chicago Anesthesia Pain Specialists, Chicago

63117

Medex Healthcare Research, Inc., St Louis

66210

Mid-America Physiatrists, P.A., Overland Park

67205

Professional Research Network of Kansas, LLC, Wichita

68134

Heartland Clinical Research, Inc., Omaha

70115

Best Clinical Trials, LLC, New Orleans

George Stanley Walker, MD, New Orleans

70601

Centex Studies, Inc, Lake Charles

71111

Willis-Knighton Physician Network/ Spine and Pain Specialist, Bossier City

Willis-Knighton Physician Network/WKB Family Medicine Associates, Bossier City

72205

KLR Business Group dba Arkansas Clinical Research, Little Rock

Lynn Institute of the Ozarks, Little Rock

Primary Care of Arkansas, P.A., Little Rock

73103

COR Clinical Research, L.L.C, Oklahoma City

Health Research of Oklahoma, Oklahoma City

73109

NPC Research, Oklahoma City

73112

Lynn Health Science Institute, Oklahoma City

75024

The Pain Relief Center, Plano

75679

Hopital Cochin, Paris

76012

KRK Medical Research, Arlington

77030

Advances In Health, Houston

77058

Centex Studies, Inc./Clear Lake Family Physicians, Houston

77074

Clinical Trial Network, Houston

78209

Quality Research, Inc., San Antonio

78213

Lee Medical Associates, PA, San Antonio

Progressive Clinical Research, PA, San Antonio

80209

Mountain View Clinical Research, Inc., Denver

Mountain View Clinical Research, Inc, Denver

80301

Alpine Clinical Research Center, Boulder

84020

Physicians Research Options, LLC, Draper

85018

The Pain Center of Arizona, Phoenix

85053

Arizona Research Center, Phoenix

85215

Ferguson Family Medicine, Mesa

85254

Valley Pain Consultants, Scottsdale

87102

Albuquerque Clinical Trials, Inc., Albuquerque

87106

New Mexico Clinical Research & Osteoporosis Center, Inc., Albuquerque

89106

Affiliated Clinical Research, Inc., Las Vegas

89117

Office of Stephen H. Miller, MD, Las Vegas

89119

Office of Robert Kaplan, DO, Las Vegas

89123

Advanced Biomedical Research of America, Las Vegas

90033

University of Southern California, Los Angeles

USC IDS Pharmacy, Los Angeles

90703

Core Healthcare Group, Cerritos

90806

Collaborative Neuroscience Network, LLC., Long Beach

91606

Providence Clinical Research, North Hollywood

91607

Bayview Research Group, Valley Village

91763

Catalina Research Institute, LLC, Montclair

91911

eStudySite, Chula Vista

91942

eStudySite, La Mesa

91978

Encompass Clinical Research, Spring Valley

92020

Triwest Research Associates, LLC, El Cajon

92103

Artemis Institute for Clinical Research, San Diego

92595

Elite Clinical Trials, Inc., Wildomar

92801

Anaheim Clinical Trials, LLC, Anaheim

92845

Collaborative Neuroscience Network, LLC., Garden Grove

93702

Research Center of Fresno, Inc., Fresno

93710

Neuro-Pain Medical Center, Fresno

93720

Valley Research-Trials, Fresno

94598

Diablo Clinical Research, Inc., Walnut Creek

95821

Northern California Research, Sacramento

96814

East-West Medical Research Institute, Honolulu

98004

Washington Center for Pain Management, Bellevue

98007

Northwest Clinical Research Center, Bellevue

06606

New England Research Associates, LLC, Bridgeport

06460

My Health 1st Urgent Care, Milford

06905

Stamford Therapeutics Consortium, Stamford

02115

Brigham and Women's Hospital, Boston

02467

Brigham and Women's Hospital, Chestnut Hill

02169

Beacon Clinical Research, LLC, Quincy

02472

MedVadis Research Corporation, Watertown

03801

ActivMed Practices & Research, Inc., Portsmouth

08009

Comprehensive Clinical Research, Berlin

08053

CRI Worldwide, LLC, Marlton

08873

University Clinical Research Center, Somerset

08611

Premier Research, Trenton

02886

Omega Medical Research, Warwick

L3Y 5G8

SKDS Research Inc., Newmarket

N7T 4X3

London Road Diagnostic Clinic & Medical Centre, Sarnia

G1V 3M7

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc., Québec

G1W 4R4

Centre de recherche Saint-Louis, Québec

J1L 0H8

Diex Research Sherbrooke Inc., Sherbrooke

480-1195

Aichi Medical University Hospital, Nagakute

466-8560

Nagoya University Hospital, Showa-ku, Nagoya

260-8677

Chiba University Hospital, Chuo-ku, Chiba

273-8588

Funabashi Municipal Medical Center, Funabashi

290-0003

Chiba Rosai Hospital, Ichihara

264-0017

Chiba Central Medical Center, Wakaba-ku, Chiba

813-0017

Fukuoka Mirai Hospital, Higashi-ku,Fukuoka

800-0296

Kyushu Rosai Hospital, Kokuraminami-ku,Kitakyushu

831-0016

Takagi Hospital, Ōkawa

969-3492

Fukushima Medical University Aizu Medical Center, Aizu-Wakamatsu

040-8585

Hakodate Central General Hospital, Hakodate

041-0802

Hakodate Ohmura Orthopedic Hospital, Hakodate

658-0011

Kobe Konan Yamate Clinic, Higashinada-ku, Kobe

670-0976

Omuro Orthopedic Clinic, Himeji

675-1115

Medical corporate corporation hoshikai Onishi medical clinic, Kako-gun

651-0073

Kobe Red Cross Hospital, Kobe

920-8650

National Hospital Organization Kanazawa Medical Center, Kanazawa

923-8507

Morita Hospital, Komatsu

390-8601

Marunouchi Hospital, Matsumoto

874-0011

National Hospital Organization Beppu Medical Center, Beppu

577-0011

Sobajima Clinic, Higashiosaka

598-8577

Rinku General Medical Center, Izumisano

559-0012

Minamiosaka Hospital, Suminoe-ku, Osaka

360-0816

Saitama Jikei Hospital, Kumagaya

431-3192

Hamamatsu University School of Medicine, University Hospital, Hamamatsu

113-8519

Tokyo Medical and Dental University Medical Hospital, Bunkyo-ku

197-8511

Fussa Hospital, Fussa

108-0073

Tokyo Saiseikai Central Hospital, Minato-ku

140-0001

Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital, Shinagawa-ku

140-0014

Ohimachi Orthopaedic Clinic, Shinagawa-ku

160-8582

Keio University Hospital, Shinjuku-ku

992-8502

Yonezawa City Hospital, Yonezawa

750-8520

Shimonoseki City Hospital, Shimonoseki-shi

755-8505

Yamaguchi University Hospital, Ube

813-8501

Chihaya Hospital, Fukuoka

814-0165

Kuroda Orthopedic Hospital, Fukuoka

960-1295

Fukushima Medical University Hospital, Fukushima

730-8619

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima

336-8522

Saitama Municipal Hospital, Saitama

930-0194

Toyama University Hospital, Toyama

03080

CTC Pharmacy, Seoul National University Hospital, Seoul

Seoul National University Hospital, Seoul

03722

CTC Pharmacy, Severance Hospital, Seoul

Severance Hospital, Seoul

06351

Clinical Trial Pharmacy, Samsung Medical Center, Seoul

Samsung Medical Center, Seoul

03004

Instituto de Ciencias Medicas, Alicante

08003

Hospital de Mar Servicio de Radiologia, Barcelona

Hospital del Mar Servicio de Farmacia, Barcelona

08006

Specialist, S.L., Barcelona

Specialist. Farmacia, Barcelona

08024

Hospital del Mar, Barcelona

08025

Hospital Universitario Quiron-Dexeus, Barcelona

08028

Hospital Universitario Quiron-Dexeus. Servicio de Farmacia, Barcelona

08034

Hospital Sanitas CIMA, Barcelona

413 45

CTC (Clinical Trial Center) Sahlgrenska University Hospital, Gothenburg

252 20

Pharmasite, Helsingborg

111 37

ProbarE i Stockholm AB, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Pfizer

INDUSTRY

NCT02528253 - A Phase 3 Study of Tanezumab for Chronic Low Back Pain | Biotech Hunter | Biotech Hunter