A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

PHASE2CompletedINTERVENTIONAL
Enrollment

1,457

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

October 31, 2011

Study Completion Date

November 30, 2011

Conditions
Osteoarthritis
Interventions
DRUG

SD-6010

200 mg tablets once a day for 2 years

DRUG

SD-6010

50 mg tablets once a day for 2 years

DRUG

Placebo

Placebo tablets once a day for 2 years

Trial Locations (183)

1126

Orszagos Gerincgyogyaszati Kozpont, Budapest

1200

Cliniques Universitaires St Luc, Brussels

2900

Selye Janos Korhaz, Reumatologiai Szakrendelo, Komárom

3000

Universitair Ziekenhuis Gasthuisberg / Rheumatology, Leuven

3300

Heves Megyei Onkormanyzat Markhot Ferenc Korhaz, Eger

5700

Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz, Reumatologia, Gyula

7000

Menzies Research Institute, Hobart

10003

NYU Hospital for Joint Diseases, New York

11000

Nemocnice Na Frantisku s poliklinikou, Prague

12247

Praxis fuer Orthopaedie, Berlin

13125

Klinische Forschung Berlin-Buch, Berlin

13210

Crouse Medical Practice, PLLC d/b/a Internist Associates of Central New York, Syracuse

13760

Regional Clinical Research, Inc., Endwell

14625

VirtualScopics, Inc., Rochester

15705

Hospital Ntra. Sra. de La Esperanza, Santiago de Compostela

16011

Azienda Sanitaria Genovese, Ospedale La Colletta, Dipartimento Apparato Locomotore, Arenzano

16635

Altoona Center for Clinical Research, Duncansville

18015

East Penn Rheumatology Associates, PC, Bethlehem

18940

BioImaging Technologies, Inc., Newtown

19002

Hospital General Universitario de Guadalajara, Guadalajara

19055

Klinische Forschung Schwerin, Schwerin

20157

Ospedale Luigi Sacco, Azienda Ospedaliera Polo Universitario Unita' Operativa di Reumatologia, Milan

20850

The Center for Rheumatology and Bone Research, Rockville

20902

The Center for Rheumatology and Bone Research, Wheaton

23294

National Clinical Research, Incorporated, Richmond

23454

Advanced Pain Management, Virginia Beach

23502

National Clinical Research - Norfolk, Inc., Norfolk

27215

Kernodle Clinic Inc., Burlington

27407

Southeastern Radiology, Greensboro

27408

PharmQuest, Greensboro

28117

Research Institute of the Carolinas, PLLC, Mooresville

28144

PMG Research of Salisbury, Salisbury

28401

Carolina Arthritis Associates, PA, Wilmington

PMG Research of Wilmington, LLC, Wilmington

28625

Piedmont Healthcare/Research, Statesville

29407

Rheumatology Associates, Charleston

29651

Radiant Research, Inc., Greer

30060

North Georgia Clinical Research, Marietta

30189

North Georgia Clinical Research, Woodstock

32216

Jacksonville Center for Clincal Research, Jacksonville

Memorial Hospital Jacksonville, Jacksonville

32607

Southeastern Arthritis Center, Gainesville

Southeastern Imaging & Diagnostics, Gainesville

Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute, Gainesville

33317

Gold Coast Research, LLC, Plantation

Marin E. Hale, M.D., P.A., Plantation

33324

Sabiha Khan, M.D., Plantation

33407

Kanner, Mendelson, Shteinman, LLC, West Palm Beach

Radiant Research, West Palm Beach

Rheumatology and Endocrinology Specialists of the Palm Beaches, P.A., West Palm Beach

35209

Brookwood Internists, P.C., Birmingham

35242

Greystone Medical Center, Birmingham

36251

Praxis fuer Orthopaedie, Chirotherapie und Akupunktur, Bad Hersfeld

37334

Parkway Medical Group, Fayetteville

37660

Holston Medical Group, Kingsport

37920

D. Matthew Sellers MD PC, Knoxville

38125

Southwind Medical Specialists, Memphis

38801

North Mississippi Medical Center, Inc., Tupelo

39150

Planters Clinic, Port Gibson

39232

Arthritis and Osteoporosis Treatment and Research Center, Flowood

40213

L-MARC Research Center, Louisville

40517

Office of Manoj Kohli, M.D., Lexington

41014

Hospital Nuestra Señora de Valme, Seville

42431

Commonwealth Biomedical Research, LLC, Madisonville

43213

Columbus Clinical Research, Inc., Columbus

43235

Optimed Research, LLC, Columbus

44122

Advantage Diagnostics, Beachwood

Rapid Medical Research, Inc., Cleveland

44124

Lake Health Lyndhurst Clinic, Lyndhurst

46123

Ronald Keith Stegemoller, American Health Network, Avon

47150

Floyd Memorial Hospital, New Albany

49601

Cadillac Clinical Research, LLC, located at Great Lakes Family Care, Cadillac

53142

Clinical Investigation Specialists, Inc., Kenosha

58103

Internal Medicine Associates, Fargo

Lillestol Research, LLC, Fargo

60025

NorthShore University HealthSystem, Glenview

60031

Clinical Investigation Specialists, Inc., Gurnee

60035

Presidio Ospedaliero Augusto Murri, Reparto di Reumatologia, Jesi (Ancona)

60053

Illinois Bone and Joint Institute, LLC, Morton Grove

60061

NorthShore University HealthSystem, Vernon Hills

60201

NorthShore University HealthSystem, Evanston

60611

Preventive Medicine, Chicago

Rehabilitation Institue of Chicago, Chicago

62704

The Arthritis Center, Springfield

63011

Mercy Medical Group/Woodlake Research, Clarkson Valley

64114

Dynamic Clinical Research, Inc., Kansas City

Joan Prouty Moore, MD, Kansas City

Orthopaedic and Occupational Medicine, Kansas City

The Center for Pharmaceutical Research, P.C., Kansas City

67205

Heartland Research Associates, LLC, Wichita

67207

Family Medicine East, Chartered/Radiology, Wichita

Heartland Research Associates, LLC, Wichita

71115

TFD Research, LLC, Shreveport

72205

Martin Bowen Hefley Orthopedics, Little Rock

Teton Research, LLC, Little Rock

73326

Praxis Dr. Thomas Jung, Deggingen

75231

Baylor Research Institute, Dallas

Metroplex Clinical Research Center, Dallas

78217

Radiant Research San Antonio Northeast, San Antonio

South Texas Radiology Imaging Center, San Antonio

78218

Oakwell Clinical Research, LLC, San Antonio

80209

Denver Internal Medicine Group, Denver

Mountain View Clinical Research, Inc., Denver

80401

New West Physicians Clinical Research, Golden

84047

Pivotal Research Centers, Midvale

85023

Arizona Research Center, Phoenix

85027

Pivotal Research Centers, Phoenix

85381

Pivotal Research Centers, Peoria

85724

University of Arizona, Tucson

89106

Affiliated Clinical Research, Inc., Las Vegas

89109

Office of Michael Mall, M.D., Las Vegas

89117

Nevada Imaging Centers, Las Vegas

89118

Nevada Imaging Centers, Las Vegas

89128

Office of Danka Michaels, MD, Las Vegas

89144

Office of Stephen H. Miller, MD, Las Vegas

92128

Scripps Clinic-Clinical Research, San Diego

92627

College Hospital Costa Mesa, Costa Mesa

NeuroNetwork Trials, Costa Mesa

92704

Plaza Medical Imaging, Santa Ana

95608

Med Center, Carmichael

95628

Med Investigations, Inc., Fair Oaks

95661

Sierra Clinical Research, Roseville

95817

University of California Davis Health System, Sacramento

University of California Davis, Sacramento

96814

East-West Medical Research Institute, Honolulu

98405

Tacoma Center for Arthritis Research, PS, Tacoma

115093

Russian State Medical University, Moscow Faculty, City Clinical Hospital #4, Moscow

115522

Institute of Rheumatology, Moscow

193312

City Alexandrovskaya Hospital, Saint Petersburg

194291

L.G. Sokolov Clinical Hospital #122 of Federal Medical-Biology Agency of Russia, Central Polyclinic, Saint Petersburg

195427

Research Institute of Traumatology and Orthopedy Named After R. R. Vredena, Saint Petersburg

06824

Advanced Radiology Consultants, Fairfield

06902

Advanced Radiology Consultants, Stamford

06905

Stamford Therapeutics Consortium, Stamford

06611

New England Research Associates, LLC, Trumbull

04102

Rheumatology Associates, Portland

02301

Miray Medical Center, Brockton

02720

Phase III Clinical Research, Fall River

02721

Fall River Clinical Research, Fall River

02740

HCI Metromedic Walk-In, New Bedford

02481-2106

MedVadis Research Corporation, Wellesley Hills

01605

Fallon Clinic, Inc. (Drug Shipment), Worcester

Fallon Clinic, Inc., Worcester

02860

Memorial Hospital of Rhode Island, Pawtucket

C1013AAR

OMI - Organización Médica de Investigación, Buenos Aires

C1034ACO

Saint Dennis Medical Group S.A., Buenos Aires

C1114AAH

Investigaciones Reumatológicas y Osteológicas S.R.L., Buenos Aires

C1405BCH

Instituto Médico Especializado (IME), Buenos Aires

C1425AWC

IMAI Research, Buenos Aires

T5M 0H4

Rheumatology Research Associates Ltd., Edmonton

A1A 5E8

Nexus Clinic Research, St. John's

L3Y 3R7

The Arthritis Program Research Group Inc., Newmarket

G1W 4R4

Centre de Rhumatologie St-Louis, Sainte-Foy

656 91

Fakultni nemocnice u sv. Anny v Brne, Brno

615 00

Revmacentrum MUDr. Mostera, s.r.o., Brno - Zidenice

370 01

MEDIPONT Plus, s.r.o., České Budějovice

MEDIPONT, s.r.o., České Budějovice

253 01

ARTMEDI UPD s r.o., Hostivice

128 50

Revmatologicky ustav, Prague

162 00

Centrum pro zdravotnicke zabezpeceni sportovni reprezentace, Prague

Ustredni vojenska nemocnice Praha, Prague

169 00

MSI - Muskuloskeletalni institut, Prague

148 00

DC Mediscan, Praha 11 - Chodov

MediCentrum Praha, a.s., Praha 11 - Chodov

760 01

Nemocnice Atlas, a.s., Zlín

PV-Medical s.r.o., Zlín

H-1036

Synexus Magyarorszag Kft., Budapest

H-5000

MAV Korhaz es Rendelointezet, Szolnok

H-8200

Veszprem Megyei Onkormanyzat Csolnoky Ferenc Korhaz-Rendelointezet, Veszprém

L-11

Clínica San Felipe, Lima

"Hospital Nacional Edgardo Rebagliati Martins - Essalud", Lima

L-27

Instituto Peruano del Hueso y la Articulación SAC., Lima

L-29

Hospital Maria Auxiliadora, Lima

Lima-27

Centro Medico Corpac, Lima

Lima 33

Centro Empresarial - Altavista Polo 4, Santiago de Surco

Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva, Santiago de Surco

Callao-02

"Hospital Nacional Alberto Sabogal Sologuren - Essalud", Callao

43-400

"NSZOZ MEDICUS II S.C. Irena Klimczak, Malgorzata Klimczak, Jerzy Klimczak", Cieszyn

50-088

"SYNEXUS SCM Sp. z o.o.", Wroclaw

50-556

Katedra i Klinika Ortopedii i Traumatologii Narzadu Ruchu, Wroclaw

826 06

V. Interna klinika FN a LF UK, Bratislava

Unknown

Ivan Ujvari, Bratislava

921 12

Narodny ustav reumatickych chorob, Piešťany

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY