Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip

PHASE3TerminatedINTERVENTIONAL
Enrollment

2,720

Participants

Timeline

Start Date

February 12, 2009

Primary Completion Date

October 28, 2010

Study Completion Date

January 12, 2011

Conditions
OsteoarthritisArthritis
Interventions
DRUG

NSAID

IV doses of placebo (to match tanezumab) every 8 weeks (through Week 48) plus oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

BIOLOGICAL

tanezumab

IV tanezumab 5 mg every 8 weeks (through Week 48) and oral placebo for NSAID BID from Weeks 2 through 56

BIOLOGICAL

tanezumab

IV tanezumab 10 mg every 8 weeks (through Week 56) and oral placebo for NSAID BID from Weeks 2 through 56

BIOLOGICAL

tanezumab

IV tanezumab 5 mg every 8 weeks (through Week 48)

DRUG

NSAID

Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

BIOLOGICAL

tanezumab

IV tanezumab 10 mg every 8 weeks (through Week 48)

DRUG

NSAID

Oral naproxen 500 mg BID for 56 weeks or oral celecoxib 100 mg BID for 56 weeks

Trial Locations (333)

1003

Rayuma Clinic, OPD , Jose Reyes Memorial Medical Center, Manila

1500

Worthwhile Clinical Trials, Benoni

1619

Clinresco Centres (Pty) Ltd, Kempton Park

1780

Asian Hospital and Medical Center, City of Muntinlupa

2060

Origin Clinical Research, Johannesburg

4091

Private Practice, Durban

Randles Road Medical Center, Durban

6000

Cebu Orthopedic Institute, Cebu City

Chong Hua Hospital, Medical Arts Center, Cebu City

Diaz Building, Cebu City

7405

Vincent Pallotti Hospital, Cape Town

7500

136 Panorama Medical Center, Panorama

TREAD Research, Parrowvalley

7550

A. Briel, Durbanville

7646

Paarl Research Center, Paarl

8000

Davao Doctors Hospital, Medical Tower, Davao City

Davao Doctors Hospital, Davao City

9301

Josha Research, Bloemfontein

10003

NYU Hospital for Joint Diseases, New York

10454

SPRI Bronx LLC, The Bronx

11201

Arthritis and Osteoporosis Associates of Brooklyn Heights, Brooklyn

11803

Prem C. Chatpar, MD, LLC, Plainview

12206

The Center for Rheumatology, LLP, Albany

14224

Southgate Medical Group, West Seneca

15006

Complejo Hospitalario Universitario de A Coruna, A Coruña

15206

Clinical Trials Research Services, LLC, Pittsburgh

15705

Hospital Nuestra Senora de la Esperanza, Servicio de Reumatologia, Santiago de Compostela, A Coruna

16602

Blair Orthopedics Associates, Altoona

19958

Rheumatology Consultants of Delaware/Delaware Arthritis, Lewes

20745

MD Medical Research, Oxon Hill

23294

National Clinical Research Richmond Inc., Richmond

23701

Doris M. Rice, M.D., F.A.C.R., Portsmouth

24018

Hypothe Test, LLC, Roanoke

27000

Unidad de Enfermedades Reumaticas y Cronico Degenerativas S.C., Coahuila

27262

Peters Medical Research, High Point

27612

Wake Internal Medicine Consultants Inc, Raleigh

Wake Research Associates, Raleigh

27834

Physicians East P. A., Greenville

Physicians East, PA, Greenville

28046

Hospital Universitario La Paz, Servicio de Reumatologia, Madrid

28144

Crescent Medical Research, Salisbury

28601

Clinical Trials of America, Inc, Hickory

28602

Piedmont Rheumatology, Hickory

29204

Columbia Arthritis Center P.A., Columbia

Southern Orthopaedic Sports Medicine, Columbia

29325

The Family Healthcare Center, PA, Clinton

29651

Radiant Research Inc, Greer

29732

The Carolina Center for Rheumatology and Arthritis Care, PA, Rock Hill

30075

ACCR/Internal Medicine, Roswell

30338

Perimeter Institute for Clinical Reseach, Inc., Atlanta

30342

Laureate Clinical Research Group, Atlanta

32117

Covance CRU, Inc., Daytona Beach

32129

Accord Clinical Research, LLC, Port Orange

32216

Jacksonville Center for Clinical Research, Jacksonville

32746

Florida Arthritis, Lake Mary

32804

Arthritis Associates, Orlando

33010

Research Consultants Group, Hialeah

33012

Palm Springs Research Institute, Hialeah

33024

University Clinical Research, Pembroke Pines

33028

Pembroke Clinical Trials, Pemkbroke Pines

33126

Pharmax Research Clinic, Inc., Miami

33155

Community Research Foundation, Miami

33180

Arthritis and Rheumatic Disease Specialties, Aventura

International Physicans Research, Aventura

Surgery Center of Aventura, Aventura

33183

International Research Associates, LLC, Miami

33189

Homestead Clinical Research Group, P.A., Cutler Bay

33324

Berma Research Group, Plantation

33542

Florida Medical Clinic, PA, Zephyrhills

33613

Stedman Clinical Trials, Tampa

33614

Tampa Medical Group, PA, Tampa

33713

Dale G. Bramlet, MD, P.L., St. Petersburg

33765

Clinical Research of West Florida, Inc., Clearwater

33781

Advent Clinical Research Center Inc, Pinellas Park

Advent Clinical Research Centers, Pinellas Park

33912

Internal Medicine Associates, Fort Myers

33916

Clinical Physiology Associates, Clinical Study Center, Fort Myers

34102

Jeffrey Alper MD Research, Naples

34202

HeartCare, Bradenton

34232

HeartCare Research, Sarasota

Kennedy-White Orthopaedic Center, Sarasota

Sarasota Center for Clinical Research, Sarasota

34233

Lovelace Scientific Resources, Sarasota

The Arthritis Specialty Centre, Sarasota

34429

Nature Coast Clinical Research, Crystal River

34471

American Family Medicine, Ocala

Renstar Medical Research, Ocala

34684

Arthritis Research of Florida, Inc., Palm Harbor

34698

Robert W. Levin MD, Dunedin

35205

Rheumatology Associates, P.C., Birmingham

35209

Radiant Research, Birmingham

35215

Alliance Clinical Research, Birmingham

35216

Shades Mountain Imaging, Birmingham

35801

Rheumatology Associates of North Alabama, PC, Huntsville

Saadat Ansari, MD Office, Huntsville

36117

Office of Vaughn H. Mancha, Jr., MD, Montgomery

36608

Coastal Clinical Research, Inc., Mobile

38119

Ramesh C. Gupta, M.D., Memphis

38305

Arthritis Clinic, Jackson

38654

Olive Branch Family Medical Center, Olive Branch

39466

Highland Community Hospital, Picayune

Mississippi Medical Research, Picayune

39531

The Center for Clinical Trials, Biloxi

40503

Pain Treatment Center of the Bluegrass, Lexington

Pasadena Pharmacy, Lexington

41014

Hospital Nuestra Senora de Valme, Servicio de Reumatologia, Seville

41700

Hospital El Tomillar, Dos Hermanas

42431

Commonwealth Biomedical Research, LLC, Madisonville

Multicare Specialists, Madisonville

42701

Center for Arthritis and Osteoporosis, Elizabethtown

43213

Columbus Clinical Research, Inc., Columbus

43235

Optimed Research, LTD, Columbus

44130

Southwest Rheumatology and Research Group, LLC, Middleburg Heights

44143

David R. Mandel, MD, Inc, Mayfield

44313

Daystar Clinical Research, Inc., Akron

45242

New Horizons Clinical Research, Cincinnati

45246

Doctor's Urgent Care Offices, Cincinnati

Sterling Research Group, Cincinnati

45408

STAT Research, Inc., Dayton

45415

Dayton Science Institute (DSI), Dayton

45432

Hometown Urgent Care and Research, Dayton

45439

PHP - Center for Clinical Research, Dayton

46123

American Health Network of Indiana, LLC, Avon

47714

MediSphere Medical Research Center, LLC, Evansville

48025

Quest Research Institute, Bingham Farms

48903

Hospital de Cruces, Servicio de Reumatologia, Barakaldo (Vizcaya)

48917

PCM Medical Services, Lansing

49009

Rheumatology PC, Kalamazoo

49684

Medical Research Associates, Traverse City

50265

Integrated Clinical Trial Services, Inc, West Des Moines

54650

Gundersen Clinic Ltd., Onalaska

57701

Regional Health Clinical Research, Rapid City

Regional Medical Clinical-Rheumatology, Rapid City

58002

Chernivtsi Regional Clinical Hospital, Chernivtsi

58103

Internal Medicine Associates, Fargo

Lillestol Research, LLC, Fargo

60061

Deerbrook Medical Associates, Vernon Hills

60611

Rehabilitation Institute of Chicago, Chicago

61107

Rockford Orthopedic Associates, Rockford

62702

Springfield Clinic, Springfield

62703

Springfield Clinical Research Department, Springfield

63031

No. County Internal Medicine & Rheumatology, Florissant

63117

Medex Healthcare Research, Inc., St Louis

63131

Rheumatology and Internal Medicine Associates of West County, P.C., St Louis

63141

A & A Pain Institute, St Louis

Arthritis Consultants Inc., St Louis

64114

Dynamic Clinical Research, Inc., Kansas City

Joan Prouty Moore, Kansas City

Orthopaedic & Occupational Medicine, Kansas City

66211

Vince and Associates Clinical Research, Overland Park

66212

Vince and Associates Clinical Research, Overland Park

68114

Westroads Medical Group, Omaha

68516

Physician Research Collaboration, LLC, Lincoln

69600

Municipal institution :Zaporizhzhya Regional Clinical Hospital, Zaporizhzhya

70808

Gulf Coast Research, LLC, Baton Rouge

The Bone and Joint Clinic, Baton Rouge

72205

Little Rock Diagnostic Clinic, PA, Little Rock

Little Rock Family Practice Clinic, Little Rock

73013

McBride Clinic, Inc, Oklahoma City

73069

Integris Family Care of Norman, Norman

LION Research, Norman

73071

Central Sooner Research, Norman

Elise Wiesner, MD, Norman

73072

McBride Clinic, Inc, Norman

McBride Clinic, Norman

73099

Aquilo Clinical Research, Yukon

73103

Bone and Joint Hospital at St. Anthony, Oklahoma City

Christine Codding, MD, Oklahoma City

Health Research of Oklahoma, Oklahoma City

Mc Bride Clinic, Oklahoma City

73112

Lynn Health Science Institute, Oklahoma City

73119

Associated Orthopedics, Inc., Oklahoma City

Hillcrest Clinical Research, Oklahoma City

74136

Rheumatology Associates Inc, Tulsa

75075

Plano Primary Care Clinic, Plano

75093

Advanced Family Medical Care, Plano

75150

Southwest Rheumatology, PA, Mesquite

75231

Metroplex Clinical Research Center, Dallas

76508

Scott & White Healthcare, Temple

77030

One Step Diagnostic, Houston

77034

Accurate Clinical Research, Houston

77055

Miracle Medical Center, Houston

77070

DM Clinical Research, Houston

77375

Martin Diagnostic Clinic, Tomball

77479

Sugar Land Med-Ped, PA, Sugar Land

77504

Philip Blum, Pasadena

77584

Pearland Primary Care Associates, Pearland

Southwest Clinical Research Centers, LLC, Pearland

78130

Hill Country Medical Associates, New Braunfels

Neurology Clinic of Central Texas, New Braunfels

78212

Alamo Clinical Research Associates, San Antonio

Alamo Clinical Research Consultants, San Antonio

78217

Texas Arthritis Research Center, PA, San Antonio

78229

Clinical Trials of Texas, Inc., San Antonio

Innovative Clinical Trials, San Antonio

Radiant Research San Antonio, San Antonio

SAM Clinical Research Center, San Antonio

San Antonio Preventive & Diagnostic Medicine, PA, San Antonio

South Texas Radiology Imaging Center, San Antonio

The Rehab Group, San Antonio

78745

Tekton Research, Inc., Austin

78746

Dr. Paul K. Pickrell (Physician's Office), Austin

79410

Gill Orthopedic Center, Lubbock

Robert R. King, M.D., Lubbock

79601

Abilene Arthritis Center, Abilene

80113

Colorado Arthritis Center, PC, Englewood

80909

Colorado Springs Family Practice, Colorado Springs

Lynn Institute of the Rockies, Colorado Springs

83000

City Clinical Hospital #5, Donetsk

83045

V.K. Gusak Institute of Urgent and Recovery Surgery, Donetsk

83404

Institute of Arthritis Research, Idaho Falls

83686

Saltzer Medical Group PA, Nampa

84047

Pivotal Research Centers, Midvale

84102

Optimum Clinical Research, Inc., Salt Lake City

84107

Radiant Research, Inc., Salt Lake City

85018

Elite Clinical Studies, LLC, Phoenix

85037

Arizona Arthritis & Rheumatology Associates, P.C., Phoenix

85202

Arizona Arthritis & Rheumatology Associates, P.C., Mesa

85210

Pivotal Research Centers, Mesa

85225

Radiant Research - Phoenix Southeast, Chandler

85253

Arizona Arthritis & Rheumatology Research, PLLC, Paradise Valley

85282

Premiere Phamaceutical Research, LLC, Tempe

85381

Pivotal Research Centers, Peoria

85395

Dedicated Clinical Research, Goodyear

85614

Eclipse Clinical Research, Green Valley

85635

Cochise Clinical Research, Sierra Vista

85710

Radiant Research, Tucson

85712

Quality of Life Medical and Research Center, Tucson

Tucson Orthopaedic Institute, Tucson

86403

Midwest Internal Medicine, PLLC, Lake Havasu City

90025

Peak Health Medical Group, Inc., Los Angeles

90712

Lakewood Orthopedic Medical & Surgical Group, Lakewood

Premier Clinical Research LLC., Lakewood

90808

Prohealth Partners, Long Beach

91361

Westlake Medical Center, Westlake Village

91911

eStudySite, Chula Vista

91942

Triwest Research, La Mesa

91950

Synergy Clinical Research Center, National City

92056

eStudySite, Oceanside

92108

San Diego Arthritis Medical Clinic, San Diego

92262

Desert Medical Group Inc., Desert Oasis Healthcare, Palm Springs

92270

Advances in Medicine, Rancho Mirage

92701

Trinity Clinical Trials, Santa Ana

92705

Apex Research Institute, Santa Ana

92801

Advanced Clinical Research Institute, Anaheim

Orange County Clinical Trials, Inc., Anaheim

94118

Kaiser Permanente Medical Center, San Francisco

95124

eStudySite, San Jose

95204

St. Joseph Medical Associates, Stockton

95608

Med Center, Carmichael

95628

Med Investigations, Inc., Fair Oaks

95823

Mercy Imaging Center, Sacramento

95831

Northern Clinical Research, Sacramento

96814

East-West Medical Research Institute, Honolulu

97701

Bend Memorial Clinic, Bend

97702

Bend Memorial Clinic, Bend

98007

Northwest Clinical Research Center, Bellevue

115093

State Healthcare Institution Moscow City Clinical Hospital #4, Moscow

115446

State Healthcare Institution: Moscow City Clinical Hospital #7, Moscow

115522

Institution Of Russian Academy of Medical Sciences, Moscow

194291

Federal State Healthcare Institution Clinical Hospital #122 n.a.Sokolov, Saint Petersburg

196247

"Saint-Petersburg State Healthcare Institution City Hospital #26", Saint Petersburg

197022

Saint Petersburg State Medical University named after Pavlov, Saint Petersburg

226018

CSM Medical University, Department of Rheumatology, Lucknow

500003

Krishna Institute of Medical Sciences Ltd., Department of Rheumatology, Secunderabad

560034

St. Johns Medical College Hospital, Department of Orthopaedics, Bangalore

560054

M.S. Ramaiah Memorial Hospital, Department of Orthopaedics, Bangalore

560079

ChanRe Rheumatology & Immunology Center & Research, Bangalore

641004

PSG Institute of Medical Sciences and Research, Coimbatore

85712-2142

Arizona Research Associates, Tucson

92103-6204

California Research Foundation, San Diego

06606

Joao MA Nascimento, MD, Bridgeport

06611

New England Research Associates, LLC, Trumbull

33054-3818

Sunshine Research Center, Opa-locka

33609-3018

Soutwest Florida Clinical Research Center, Tampa

83642-6356

Idaho Arthritis & Osteoporosis Center, PC, Meridian

02301

Beacon Clinical Research, Brockton

01201

Berkshire Rheumatology, Pittsfield

02472

MedVadis Research Corporation, Watertown

48910-8595

Justus J Fiechtner, MD, Lansing

08817

Anderson and Collins Clinical Research Inc., Edison

07202

Central Jersey Medical Research Center, Elizabeth

07728

Arthritis & Osteoporosis Associates, P.A., Freehold

08035

Mark Fisher, MD, FACRUC, Haddon Heights

07055

New Jersey Physicians, LLC, Passaic

07666

Rheumatology Associates of North Jersey, Teaneck

08757

Arthritis & Osteoporosis Associates, Toms River

08611

Premier Research, Trenton

08043

Arthritis, Rheumatic & Back Disease Associates, Voorhees Township

02886

Omega Medical Research, Warwick

98405-2308

Tacoma Center for Arthritis Research, PS, Tacoma

B0J 2C0

Office of Diane Wilson, Lunenburg

L8N 2B6

MAC Research Inc., Hamilton

N2M 5N6

KW Musculoskeletal Research Inc., Kitchener

L3Y 3R7

The Arthritis Program Research Group, Newmarket

L3Y 5G8

SKDS Research Inc., Newmarket

L2N 7E4

Dr. Saeed Shaikh, St. Catharines

M9V 4B4

Dr. Anil Gupta, Toronto

G1V 3M7

Groupe de Recherche en Rhumatologie et Maladies Osseuses, Québec

G1W 4R4

Clinique Medicale St-Louis, Québec

J7P 4J2

Polyclinique St. Eustache, Saint-Eustache

J1H 1Z1

Diex Research Sherbrooke Inc., Sherbrooke

G8Z 1Y2

Centre de Recherche Musculo-Squelettique, Trois-Rivières

Unknown

Hospital Pablo Tobon Uribe, Medellín

Centro Integral de Reumatologia e Inmunologia CIREI, Bogota

Riesgo de Fractura S.A., Bogota-Cundinamarca

Clinica Las Americas, Medellín

Reumatologya S.A., Medellín

Chinese General Hospital and Medical Center, Out Patient Department, Manila

Tiervlei Trial Center, Bellville

575 001

KMC Hospital, Department of Orthopaedics, Mangalore

411 005

Sancheti Hospital, Pune

CP 44280

"URHIA(Unidad de Investigacion en Reumatologia)Hospital Civil de GuadalajaraFray Antonio Alcalde", Guadalajara

CP 80230

"Hospital General de Culiacan, S.S., Dr. Bernardo Gastelum.", Culiacan Sinaloa

C.P. 37000

Hospital Aranda de la Parra, Leon Gto

CP 27000

Beneficencia Espanola de la Laguna, Torreon Coahuila

1056 AB

READE, Amsterdam

6525 GA

UMC St. Radboud, Nijmegen

3584 CX

UMC Utrecht, Utrecht

0122

Phelang Private Hospital Research Unit, Mamelodi East

0083

Clinical Research Unit, Pretoria

700-721

Kyungpook National University Hospital, Daegu

400-711

Inha University Hospital, Incheon

110-744

Seoul National University Hospital, Seoul

133-792

Hanyang University Hospital, Seoul

137-701

The Catholic University of Korea, Seoul St.Mary's Hospital, Seoul

08208

Corporacio Sanitaria Parc Tauli de Sabadell, Servicio de Reumatologia, Sabadell

08034

Clinica CIMA, Barcelona

Servicio de Reumatologia,Institut Ferran de Reumatologia-Clinica CIMA, Barcelona

01601

Kiev City Oleksandrivska Clinical Hospital, Kiev

02125

Kiev City Clinical Hospital #3, Kiev

03115

"State Institution Research Centre for Radiation Medicine AMS of Ukraine", Kiev

04114

"State Institution Institute of Gerontology AMS of Ukraine", Kiev

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY