A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
NCT ID: NCT00565812
Last Updated: 2016-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1457 participants
INTERVENTIONAL
2007-11-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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200 mg
High dose active comparator
SD-6010
200 mg tablets once a day for 2 years
50 mg
Low dose active comparator
SD-6010
50 mg tablets once a day for 2 years
Placebo
Placebo comparator to be used for control purposes
Placebo
Placebo tablets once a day for 2 years
Interventions
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SD-6010
200 mg tablets once a day for 2 years
SD-6010
50 mg tablets once a day for 2 years
Placebo
Placebo tablets once a day for 2 years
Eligibility Criteria
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Inclusion Criteria
* In the past, has been diagnosed with knee OA
* Radiographic evidence of OA in the study knee
Exclusion Criteria
* Current conditions in the study knee that would confound efficacy
* Selected, traditional clinical safety and laboratory parameters
40 Years
99 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Brookwood Internists, P.C.
Birmingham, Alabama, United States
Greystone Medical Center
Birmingham, Alabama, United States
Pivotal Research Centers
Peoria, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Pivotal Research Centers
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Martin Bowen Hefley Orthopedics
Little Rock, Arkansas, United States
Teton Research, LLC
Little Rock, Arkansas, United States
Med Center
Carmichael, California, United States
College Hospital Costa Mesa
Costa Mesa, California, United States
NeuroNetwork Trials
Costa Mesa, California, United States
Med Investigations, Inc.
Fair Oaks, California, United States
Sierra Clinical Research
Roseville, California, United States
University of California Davis Health System
Sacramento, California, United States
University of California Davis
Sacramento, California, United States
Scripps Clinic-Clinical Research
San Diego, California, United States
Plaza Medical Imaging
Santa Ana, California, United States
Denver Internal Medicine Group
Denver, Colorado, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, United States
New West Physicians Clinical Research
Golden, Colorado, United States
Advanced Radiology Consultants
Fairfield, Connecticut, United States
Advanced Radiology Consultants
Stamford, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
New England Research Associates, LLC
Trumbull, Connecticut, United States
Southeastern Arthritis Center
Gainesville, Florida, United States
Southeastern Imaging & Diagnostics
Gainesville, Florida, United States
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
Gainesville, Florida, United States
Jacksonville Center for Clincal Research
Jacksonville, Florida, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, United States
Gold Coast Research, LLC
Plantation, Florida, United States
Marin E. Hale, M.D., P.A.
Plantation, Florida, United States
Sabiha Khan, M.D.
Plantation, Florida, United States
Kanner, Mendelson, Shteinman, LLC
West Palm Beach, Florida, United States
Radiant Research
West Palm Beach, Florida, United States
Rheumatology and Endocrinology Specialists of the Palm Beaches, P.A.
West Palm Beach, Florida, United States
North Georgia Clinical Research
Marietta, Georgia, United States
North Georgia Clinical Research
Woodstock, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Preventive Medicine
Chicago, Illinois, United States
Rehabilitation Institue of Chicago
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
NorthShore University HealthSystem
Glenview, Illinois, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, United States
Illinois Bone and Joint Institute, LLC
Morton Grove, Illinois, United States
The Arthritis Center
Springfield, Illinois, United States
NorthShore University HealthSystem
Vernon Hills, Illinois, United States
Ronald Keith Stegemoller, American Health Network
Avon, Indiana, United States
Floyd Memorial Hospital
New Albany, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Family Medicine East, Chartered/Radiology
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Office of Manoj Kohli, M.D.
Lexington, Kentucky, United States
L-MARC Research Center
Louisville, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
TFD Research, LLC
Shreveport, Louisiana, United States
Rheumatology Associates
Portland, Maine, United States
The Center for Rheumatology and Bone Research
Rockville, Maryland, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Miray Medical Center
Brockton, Massachusetts, United States
Phase III Clinical Research
Fall River, Massachusetts, United States
Fall River Clinical Research
Fall River, Massachusetts, United States
HCI Metromedic Walk-In
New Bedford, Massachusetts, United States
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States
Fallon Clinic, Inc. (Drug Shipment)
Worcester, Massachusetts, United States
Fallon Clinic, Inc.
Worcester, Massachusetts, United States
Cadillac Clinical Research, LLC, located at Great Lakes Family Care
Cadillac, Michigan, United States
Arthritis and Osteoporosis Treatment and Research Center
Flowood, Mississippi, United States
Planters Clinic
Port Gibson, Mississippi, United States
North Mississippi Medical Center, Inc.
Tupelo, Mississippi, United States
Mercy Medical Group/Woodlake Research
Clarkson Valley, Missouri, United States
Dynamic Clinical Research, Inc.
Kansas City, Missouri, United States
Joan Prouty Moore, MD
Kansas City, Missouri, United States
Orthopaedic and Occupational Medicine
Kansas City, Missouri, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, United States
Office of Michael Mall, M.D.
Las Vegas, Nevada, United States
Nevada Imaging Centers
Las Vegas, Nevada, United States
Nevada Imaging Centers
Las Vegas, Nevada, United States
Office of Danka Michaels, MD
Las Vegas, Nevada, United States
Office of Stephen H. Miller, MD
Las Vegas, Nevada, United States
Regional Clinical Research, Inc.
Endwell, New York, United States
NYU Hospital for Joint Diseases
New York, New York, United States
VirtualScopics, Inc.
Rochester, New York, United States
Crouse Medical Practice, PLLC d/b/a Internist Associates of Central New York
Syracuse, New York, United States
Kernodle Clinic Inc.
Burlington, North Carolina, United States
Southeastern Radiology
Greensboro, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
Research Institute of the Carolinas, PLLC
Mooresville, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Carolina Arthritis Associates, PA
Wilmington, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
Internal Medicine Associates
Fargo, North Dakota, United States
Lillestol Research, LLC
Fargo, North Dakota, United States
Advantage Diagnostics
Beachwood, Ohio, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, United States
Optimed Research, LLC
Columbus, Ohio, United States
Lake Health Lyndhurst Clinic
Lyndhurst, Ohio, United States
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
BioImaging Technologies, Inc.
Newtown, Pennsylvania, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States
Rheumatology Associates
Charleston, South Carolina, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Parkway Medical Group
Fayetteville, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
D. Matthew Sellers MD PC
Knoxville, Tennessee, United States
Southwind Medical Specialists
Memphis, Tennessee, United States
Baylor Research Institute
Dallas, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, United States
South Texas Radiology Imaging Center
San Antonio, Texas, United States
Oakwell Clinical Research, LLC
San Antonio, Texas, United States
Pivotal Research Centers
Midvale, Utah, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
National Clinical Research, Incorporated
Richmond, Virginia, United States
Advanced Pain Management
Virginia Beach, Virginia, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, United States
OMI - Organización Médica de Investigación
Buenos Aires, , Argentina
Saint Dennis Medical Group S.A.
Buenos Aires, , Argentina
Investigaciones Reumatológicas y Osteológicas S.R.L.
Buenos Aires, , Argentina
Instituto Médico Especializado (IME)
Buenos Aires, , Argentina
IMAI Research
Buenos Aires, , Argentina
Menzies Research Institute
Hobart, Tasmania, Australia
Cliniques Universitaires St Luc
Brussels, , Belgium
Universitair Ziekenhuis Gasthuisberg / Rheumatology
Leuven, , Belgium
Rheumatology Research Associates Ltd.
Edmonton, Alberta, Canada
Nexus Clinic Research
St. John's, Newfoundland and Labrador, Canada
The Arthritis Program Research Group Inc.
Newmarket, Ontario, Canada
Centre de Rhumatologie St-Louis
Sainte-Foy, Quebec, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, , Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno - Zidenice, , Czechia
MEDIPONT Plus, s.r.o.
České Budějovice, , Czechia
MEDIPONT, s.r.o.
České Budějovice, , Czechia
ARTMEDI UPD s r.o.
Hostivice, , Czechia
Nemocnice Na Frantisku s poliklinikou
Prague, , Czechia
Revmatologicky ustav
Prague, , Czechia
Centrum pro zdravotnicke zabezpeceni sportovni reprezentace
Prague, , Czechia
Ustredni vojenska nemocnice Praha
Prague, , Czechia
MSI - Muskuloskeletalni institut
Prague, , Czechia
DC Mediscan
Praha 11 - Chodov, , Czechia
MediCentrum Praha, a.s.
Praha 11 - Chodov, , Czechia
Nemocnice Atlas, a.s.
Zlín, , Czechia
PV-Medical s.r.o.
Zlín, , Czechia
Praxis fuer Orthopaedie, Chirotherapie und Akupunktur
Bad Hersfeld, , Germany
Praxis fuer Orthopaedie
Berlin, , Germany
Klinische Forschung Berlin-Buch
Berlin, , Germany
Praxis Dr. Thomas Jung
Deggingen, , Germany
Klinische Forschung Schwerin
Schwerin, , Germany
Orszagos Gerincgyogyaszati Kozpont
Budapest, , Hungary
Synexus Magyarorszag Kft.
Budapest, , Hungary
Heves Megyei Onkormanyzat Markhot Ferenc Korhaz
Eger, , Hungary
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz, Reumatologia
Gyula, , Hungary
Selye Janos Korhaz, Reumatologiai Szakrendelo
Komárom, , Hungary
MAV Korhaz es Rendelointezet
Szolnok, , Hungary
Veszprem Megyei Onkormanyzat Csolnoky Ferenc Korhaz-Rendelointezet
Veszprém, , Hungary
Azienda Sanitaria Genovese, Ospedale La Colletta, Dipartimento Apparato Locomotore
Arenzano, , Italy
Presidio Ospedaliero Augusto Murri, Reparto di Reumatologia
Jesi (Ancona), , Italy
Ospedale Luigi Sacco, Azienda Ospedaliera Polo Universitario Unita' Operativa di Reumatologia
Milan, , Italy
Clínica San Felipe
Lima, Lima Province, Peru
Hospital Nacional "Edgardo Rebagliati Martins" - Essalud
Lima, Lima Province, Peru
Instituto Peruano del Hueso y la Articulación SAC.
Lima, Lima Province, Peru
Hospital Maria Auxiliadora
Lima, Lima Province, Peru
Centro Medico Corpac
Lima, Lima Province, Peru
Centro Empresarial - Altavista Polo 4
Santiago de Surco, Lima region, Peru
Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva
Santiago de Surco, Lima region, Peru
Hospital Nacional "Alberto Sabogal Sologuren" - Essalud
Callao, Provincia Constitucional del Callao, Peru
NSZOZ "MEDICUS II" S.C. Irena Klimczak, Malgorzata Klimczak, Jerzy Klimczak
Cieszyn, , Poland
"SYNEXUS SCM" Sp. z o.o.
Wroclaw, , Poland
Katedra i Klinika Ortopedii i Traumatologii Narzadu Ruchu
Wroclaw, , Poland
Russian State Medical University, Moscow Faculty, City Clinical Hospital #4
Moscow, , Russia
Institute of Rheumatology
Moscow, , Russia
City Alexandrovskaya Hospital
Saint Petersburg, , Russia
L.G. Sokolov Clinical Hospital #122 of Federal Medical-Biology Agency of Russia, Central Polyclinic
Saint Petersburg, , Russia
Research Institute of Traumatology and Orthopedy Named After R. R. Vredena
Saint Petersburg, , Russia
V. Interna klinika FN a LF UK
Bratislava, , Slovakia
Ivan Ujvari
Bratislava, , Slovakia
Narodny ustav reumatickych chorob
Piešťany, , Slovakia
Hospital Ntra. Sra. de La Esperanza
Santiago de Compostela, A Coruña, Spain
Hospital General Universitario de Guadalajara
Guadalajara, Guadalajara, Spain
Hospital Nuestra Señora de Valme
Seville, Sevilla, Spain
Countries
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References
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Hellio le Graverand MP, Clemmer RS, Redifer P, Brunell RM, Hayes CW, Brandt KD, Abramson SB, Manning PT, Miller CG, Vignon E. A 2-year randomised, double-blind, placebo-controlled, multicentre study of oral selective iNOS inhibitor, cindunistat (SD-6010), in patients with symptomatic osteoarthritis of the knee. Ann Rheum Dis. 2013 Feb;72(2):187-95. doi: 10.1136/annrheumdis-2012-202239. Epub 2012 Nov 10.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2007-001457-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ITIC
Identifier Type: OTHER
Identifier Source: secondary_id
A6171016
Identifier Type: -
Identifier Source: org_study_id