Clinical trial NCT00565812: A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
Official title: A Long-Term, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Radiographic Study To Investigate The Safety And Efficacy Of Orally Administered SD-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: knee Osteoarthritis Disease Modifying Osteoarthritis Drug
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-30
Enrollment: 1457
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.


Eligibility criteria: Inclusion Criteria:

* Subjects aged \>= 40 years with a BMI \>= 25 and \<= 40 kg/m2
* In the past, has been diagnosed with knee OA
* Radiographic evidence of OA in the study knee

Exclusion Criteria:

* A diagnosis of any other rheumatic disease
* Current conditions in the study knee that would confound efficacy
* Selected, traditional clinical safety and laboratory parameters

Primary outcomes:
measure: Rate of Progression of Joint Space Narrowing
timeFrame: Baseline up to Month 24
measure: Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2
timeFrame: Baseline up to Month 24
measure: Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3
timeFrame: Baseline up to Month 24
Secondary outcomes:
measure: Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24
timeFrame: Baseline, Month 12, 24
measure: Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
timeFrame: Baseline, Month 12, 24
measure: Number of Participants With EuroQoL-5D Self-Care Domain Score
timeFrame: Baseline, Month 12, 24
measure: Number of Participants With EuroQoL-5D Usual Activity Domain Score
timeFrame: Baseline, Month 12, 24
measure: Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
timeFrame: Baseline, Month 12, 24
measure: Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
timeFrame: Baseline, Month 12, 24
measure: EuroQoL-5D Visual Analog Scale Score
timeFrame: Baseline, Month 12, 24
measure: Number of Participants With Increase in Total Analgesic Medication Use
timeFrame: Month 12, 24
measure: Number of Participants With Decrease in Total Analgesic Medication Use
timeFrame: Month 12, 24
measure: Patient Global Impression of Change Score
timeFrame: Month 24
measure: Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
timeFrame: Month 24
measure: Number of Participants With Joint Space Narrowing Progression
timeFrame: Month 24
measure: Number of Participants Applicable for Virtual Joint Replacement
timeFrame: Month 24
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 7-10 days after last dose of study drug (Week 111)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline, Month 3, 6, 12, 18, 24
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline up to Week 111
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
timeFrame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
timeFrame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96
measure: Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96
timeFrame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96
Locations:
city: Birmingham
country: United States
facility: Brookwood Internists, P.C.
state: Alabama
city: Birmingham
country: United States
facility: Greystone Medical Center
state: Alabama
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Martin Bowen Hefley Orthopedics
state: Arkansas
city: Little Rock
country: United States
facility: Teton Research, LLC
state: Arkansas
city: Carmichael
country: United States
facility: Med Center
state: California
city: Costa Mesa
country: United States
facility: College Hospital Costa Mesa
state: California
city: Costa Mesa
country: United States
facility: NeuroNetwork Trials
state: California
city: Fair Oaks
country: United States
facility: Med Investigations, Inc.
state: California
city: Roseville
country: United States
facility: Sierra Clinical Research
state: California
city: Sacramento
country: United States
facility: University of California Davis Health System
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: San Diego
country: United States
facility: Scripps Clinic-Clinical Research
state: California
city: Santa Ana
country: United States
facility: Plaza Medical Imaging
state: California
city: Denver
country: United States
facility: Denver Internal Medicine Group
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Golden
country: United States
facility: New West Physicians Clinical Research
state: Colorado
city: Fairfield
country: United States
facility: Advanced Radiology Consultants
state: Connecticut
city: Stamford
country: United States
facility: Advanced Radiology Consultants
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Gainesville
country: United States
facility: Southeastern Arthritis Center
state: Florida
city: Gainesville
country: United States
facility: Southeastern Imaging & Diagnostics
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clincal Research
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: Plantation
country: United States
facility: Marin E. Hale, M.D., P.A.
state: Florida
city: Plantation
country: United States
facility: Sabiha Khan, M.D.
state: Florida
city: West Palm Beach
country: United States
facility: Kanner, Mendelson, Shteinman, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Radiant Research
state: Florida
city: West Palm Beach
country: United States
facility: Rheumatology and Endocrinology Specialists of the Palm Beaches, P.A.
state: Florida
city: Marietta
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Chicago
country: United States
facility: Preventive Medicine
state: Illinois
city: Chicago
country: United States
facility: Rehabilitation Institue of Chicago
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone and Joint Institute, LLC
state: Illinois
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Vernon Hills
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Avon
country: United States
facility: Ronald Keith Stegemoller, American Health Network
state: Indiana
city: New Albany
country: United States
facility: Floyd Memorial Hospital
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Family Medicine East, Chartered/Radiology
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lexington
country: United States
facility: Office of Manoj Kohli, M.D.
state: Kentucky
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Shreveport
country: United States
facility: TFD Research, LLC
state: Louisiana
city: Portland
country: United States
facility: Rheumatology Associates
state: Maine
city: Rockville
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Phase III Clinical Research
state: Massachusetts
city: Fall River
country: United States
facility: Fall River Clinical Research
state: Massachusetts
city: New Bedford
country: United States
facility: HCI Metromedic Walk-In
state: Massachusetts
city: Wellesley Hills
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic, Inc. (Drug Shipment)
state: Massachusetts
city: Worcester
country: United States
facility: Fallon Clinic, Inc.
state: Massachusetts
city: Cadillac
country: United States
facility: Cadillac Clinical Research, LLC, located at Great Lakes Family Care
state: Michigan
city: Flowood
country: United States
facility: Arthritis and Osteoporosis Treatment and Research Center
state: Mississippi
city: Port Gibson
country: United States
facility: Planters Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center, Inc.
state: Mississippi
city: Clarkson Valley
country: United States
facility: Mercy Medical Group/Woodlake Research
state: Missouri
city: Kansas City
country: United States
facility: Dynamic Clinical Research, Inc.
state: Missouri
city: Kansas City
country: United States
facility: Joan Prouty Moore, MD
state: Missouri
city: Kansas City
country: United States
facility: Orthopaedic and Occupational Medicine
state: Missouri
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research, P.C.
state: Missouri
city: Las Vegas
country: United States
facility: Affiliated Clinical Research, Inc.
state: Nevada
city: Las Vegas
country: United States
facility: Office of Michael Mall, M.D.
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Imaging Centers
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Imaging Centers
state: Nevada
city: Las Vegas
country: United States
facility: Office of Danka Michaels, MD
state: Nevada
city: Las Vegas
country: United States
facility: Office of Stephen H. Miller, MD
state: Nevada
city: Endwell
country: United States
facility: Regional Clinical Research, Inc.
state: New York
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: Rochester
country: United States
facility: VirtualScopics, Inc.
state: New York
city: Syracuse
country: United States
facility: Crouse Medical Practice, PLLC d/b/a Internist Associates of Central New York
state: New York
city: Burlington
country: United States
facility: Kernodle Clinic Inc.
state: North Carolina
city: Greensboro
country: United States
facility: Southeastern Radiology
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Mooresville
country: United States
facility: Research Institute of the Carolinas, PLLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates, PA
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Fargo
country: United States
facility: Internal Medicine Associates
state: North Dakota
city: Fargo
country: United States
facility: Lillestol Research, LLC
state: North Dakota
city: Beachwood
country: United States
facility: Advantage Diagnostics
state: Ohio
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research, Inc.
state: Ohio
city: Columbus
country: United States
facility: Optimed Research, LLC
state: Ohio
city: Lyndhurst
country: United States
facility: Lake Health Lyndhurst Clinic
state: Ohio
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Newtown
country: United States
facility: BioImaging Technologies, Inc.
state: Pennsylvania
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Charleston
country: United States
facility: Rheumatology Associates
state: South Carolina
city: Greer
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Fayetteville
country: United States
facility: Parkway Medical Group
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Knoxville
country: United States
facility: D. Matthew Sellers MD PC
state: Tennessee
city: Memphis
country: United States
facility: Southwind Medical Specialists
state: Tennessee
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: South Texas Radiology Imaging Center
state: Texas
city: San Antonio
country: United States
facility: Oakwell Clinical Research, LLC
state: Texas
city: Midvale
country: United States
facility: Pivotal Research Centers
state: Utah
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Incorporated
state: Virginia
city: Virginia Beach
country: United States
facility: Advanced Pain Management
state: Virginia
city: Tacoma
country: United States
facility: Tacoma Center for Arthritis Research, PS
state: Washington
city: Kenosha
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: OMI - Organización Médica de Investigación
city: Buenos Aires
country: Argentina
facility: Saint Dennis Medical Group S.A.
city: Buenos Aires
country: Argentina
facility: Investigaciones Reumatológicas y Osteológicas S.R.L.
city: Buenos Aires
country: Argentina
facility: Instituto Médico Especializado (IME)
city: Buenos Aires
country: Argentina
facility: IMAI Research
city: Hobart
country: Australia
facility: Menzies Research Institute
state: Tasmania
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St Luc
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg / Rheumatology
city: Edmonton
country: Canada
facility: Rheumatology Research Associates Ltd.
state: Alberta
city: St. John's
country: Canada
facility: Nexus Clinic Research
state: Newfoundland and Labrador
city: Newmarket
country: Canada
facility: The Arthritis Program Research Group Inc.
state: Ontario
city: Sainte-Foy
country: Canada
facility: Centre de Rhumatologie St-Louis
state: Quebec
city: Brno - Zidenice
country: Czech Republic
facility: Revmacentrum MUDr. Mostera, s.r.o.
city: Brno
country: Czech Republic
facility: Fakultni nemocnice u sv. Anny v Brne
city: Ceske Budejovice
country: Czech Republic
facility: MEDIPONT Plus, s.r.o.
city: Ceske Budejovice
country: Czech Republic
facility: MEDIPONT, s.r.o.
city: Hostivice
country: Czech Republic
facility: ARTMEDI UPD s r.o.
city: Praha 11 - Chodov
country: Czech Republic
facility: DC Mediscan
city: Praha 11 - Chodov
country: Czech Republic
facility: MediCentrum Praha, a.s.
city: Praha 1
country: Czech Republic
facility: Nemocnice Na Frantisku s poliklinikou
city: Praha 2
country: Czech Republic
facility: Revmatologicky ustav
city: Praha 6
country: Czech Republic
facility: Centrum pro zdravotnicke zabezpeceni sportovni reprezentace
city: Praha 6
country: Czech Republic
facility: Ustredni vojenska nemocnice Praha
city: Praha 6
country: Czech Republic
facility: MSI - Muskuloskeletalni institut
city: Zlin
country: Czech Republic
facility: Nemocnice Atlas, a.s.
city: Zlin
country: Czech Republic
facility: PV-Medical s.r.o.
city: Bad Hersfeld
country: Germany
facility: Praxis fuer Orthopaedie, Chirotherapie und Akupunktur
city: Berlin
country: Germany
facility: Praxis fuer Orthopaedie
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Buch
city: Deggingen
country: Germany
facility: Praxis Dr. Thomas Jung
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin
city: Budapest
country: Hungary
facility: Orszagos Gerincgyogyaszati Kozpont
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Kft.
city: Eger
country: Hungary
facility: Heves Megyei Onkormanyzat Markhot Ferenc Korhaz
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz, Reumatologia
city: Komarom
country: Hungary
facility: Selye Janos Korhaz, Reumatologiai Szakrendelo
city: Szolnok
country: Hungary
facility: MAV Korhaz es Rendelointezet
city: Veszprem
country: Hungary
facility: Veszprem Megyei Onkormanyzat Csolnoky Ferenc Korhaz-Rendelointezet
city: Arenzano
country: Italy
facility: Azienda Sanitaria Genovese, Ospedale La Colletta, Dipartimento Apparato Locomotore
city: Jesi (Ancona)
country: Italy
facility: Presidio Ospedaliero Augusto Murri, Reparto di Reumatologia
city: Milano
country: Italy
facility: Ospedale Luigi Sacco, Azienda Ospedaliera Polo Universitario Unita' Operativa di Reumatologia
city: Santiago de Surco
country: Peru
facility: Centro Empresarial - Altavista Polo 4
state: Lima
city: Santiago de Surco
country: Peru
facility: Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva
state: Lima
city: Callao
country: Peru
facility: Hospital Nacional "Alberto Sabogal Sologuren" - Essalud
city: Lima
country: Peru
facility: Clínica San Felipe
city: Lima
country: Peru
facility: Hospital Nacional "Edgardo Rebagliati Martins" - Essalud
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulación SAC.
city: Lima
country: Peru
facility: Hospital Maria Auxiliadora
city: Lima
country: Peru
facility: Centro Medico Corpac
city: Cieszyn
country: Poland
facility: NSZOZ "MEDICUS II" S.C. Irena Klimczak, Malgorzata Klimczak, Jerzy Klimczak
city: Wroclaw
country: Poland
facility: "SYNEXUS SCM" Sp. z o.o.
city: Wroclaw
country: Poland
facility: Katedra i Klinika Ortopedii i Traumatologii Narzadu Ruchu
city: Moscow
country: Russian Federation
facility: Russian State Medical University, Moscow Faculty, City Clinical Hospital #4
city: Moscow
country: Russian Federation
facility: Institute of Rheumatology
city: St. Petersburg
country: Russian Federation
facility: City Alexandrovskaya Hospital
city: St. Petersburg
country: Russian Federation
facility: L.G. Sokolov Clinical Hospital #122 of Federal Medical-Biology Agency of Russia, Central Polyclinic
city: St. Petersburg
country: Russian Federation
facility: Research Institute of Traumatology and Orthopedy Named After R. R. Vredena
city: Bratislava
country: Slovakia
facility: V. Interna klinika FN a LF UK
city: Bratislava
country: Slovakia
facility: Ivan Ujvari
city: Piestany
country: Slovakia
facility: Narodny ustav reumatickych chorob
city: Santiago de Compostela
country: Spain
facility: Hospital Ntra. Sra. de La Esperanza
state: A Coruña
city: Guadalajara
country: Spain
facility: Hospital General Universitario de Guadalajara
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora de Valme
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.