A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
ITIC
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
3 other identifiers
interventional
1,457
14 countries
183
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
Typical duration for phase_2
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 29, 2007
CompletedFirst Posted
Study publicly available on registry
November 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
December 30, 2016
CompletedDecember 30, 2016
November 1, 2016
3.9 years
November 29, 2007
June 22, 2016
November 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of Progression of Joint Space Narrowing
Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.
Baseline up to Month 24
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2
Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Baseline up to Month 24
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3
Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Baseline up to Month 24
Secondary Outcomes (35)
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Baseline, Month 3, 6, 12, 18, 24
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Baseline, Month 3, 6, 12, 18, 24
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Baseline, Month 3, 6, 12, 18, 24
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Baseline, Month 3, 6, 12, 18, 24
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Baseline, Month 3, 6, 12, 18, 24
- +30 more secondary outcomes
Other Outcomes (6)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 7-10 days after last dose of study drug (Week 111)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Baseline, Month 3, 6, 12, 18, 24
Number of Participants With Laboratory Test Abnormalities
Baseline up to Week 111
- +3 more other outcomes
Study Arms (3)
200 mg
ACTIVE COMPARATORHigh dose active comparator
50 mg
ACTIVE COMPARATORLow dose active comparator
Placebo
PLACEBO COMPARATORPlacebo comparator to be used for control purposes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- A diagnosis of any other rheumatic disease
- Current conditions in the study knee that would confound efficacy
- Selected, traditional clinical safety and laboratory parameters
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (183)
Brookwood Internists, P.C.
Birmingham, Alabama, 35209, United States
Greystone Medical Center
Birmingham, Alabama, 35242, United States
Pivotal Research Centers
Peoria, Arizona, 85381, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Pivotal Research Centers
Phoenix, Arizona, 85027, United States
University of Arizona
Tucson, Arizona, 85724, United States
Martin Bowen Hefley Orthopedics
Little Rock, Arkansas, 72205, United States
Teton Research, LLC
Little Rock, Arkansas, 72205, United States
Med Center
Carmichael, California, 95608, United States
College Hospital Costa Mesa
Costa Mesa, California, 92627, United States
NeuroNetwork Trials
Costa Mesa, California, 92627, United States
Med Investigations, Inc.
Fair Oaks, California, 95628, United States
Sierra Clinical Research
Roseville, California, 95661, United States
University of California Davis Health System
Sacramento, California, 95817, United States
University of California Davis
Sacramento, California, 95817, United States
Scripps Clinic-Clinical Research
San Diego, California, 92128, United States
Plaza Medical Imaging
Santa Ana, California, 92704, United States
Denver Internal Medicine Group
Denver, Colorado, 80209, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209, United States
New West Physicians Clinical Research
Golden, Colorado, 80401, United States
Advanced Radiology Consultants
Fairfield, Connecticut, 06824, United States
Advanced Radiology Consultants
Stamford, Connecticut, 06902, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
New England Research Associates, LLC
Trumbull, Connecticut, 06611, United States
Southeastern Arthritis Center
Gainesville, Florida, 32607, United States
Southeastern Imaging & Diagnostics
Gainesville, Florida, 32607, United States
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
Gainesville, Florida, 32607, United States
Jacksonville Center for Clincal Research
Jacksonville, Florida, 32216, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216, United States
Gold Coast Research, LLC
Plantation, Florida, 33317, United States
Marin E. Hale, M.D., P.A.
Plantation, Florida, 33317, United States
Sabiha Khan, M.D.
Plantation, Florida, 33324, United States
Kanner, Mendelson, Shteinman, LLC
West Palm Beach, Florida, 33407, United States
Radiant Research
West Palm Beach, Florida, 33407, United States
Rheumatology and Endocrinology Specialists of the Palm Beaches, P.A.
West Palm Beach, Florida, 33407, United States
North Georgia Clinical Research
Marietta, Georgia, 30060, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Preventive Medicine
Chicago, Illinois, 60611, United States
Rehabilitation Institue of Chicago
Chicago, Illinois, 60611, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
NorthShore University HealthSystem
Glenview, Illinois, 60025, United States
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031, United States
Illinois Bone and Joint Institute, LLC
Morton Grove, Illinois, 60053, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
NorthShore University HealthSystem
Vernon Hills, Illinois, 60061, United States
Ronald Keith Stegemoller, American Health Network
Avon, Indiana, 46123, United States
Floyd Memorial Hospital
New Albany, Indiana, 47150, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
Family Medicine East, Chartered/Radiology
Wichita, Kansas, 67207, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Office of Manoj Kohli, M.D.
Lexington, Kentucky, 40517, United States
L-MARC Research Center
Louisville, Kentucky, 40213, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, 42431, United States
TFD Research, LLC
Shreveport, Louisiana, 71115, United States
Rheumatology Associates
Portland, Maine, 04102, United States
The Center for Rheumatology and Bone Research
Rockville, Maryland, 20850, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Miray Medical Center
Brockton, Massachusetts, 02301, United States
Phase III Clinical Research
Fall River, Massachusetts, 02720, United States
Fall River Clinical Research
Fall River, Massachusetts, 02721, United States
HCI Metromedic Walk-In
New Bedford, Massachusetts, 02740, United States
MedVadis Research Corporation
Wellesley Hills, Massachusetts, 02481-2106, United States
Fallon Clinic, Inc. (Drug Shipment)
Worcester, Massachusetts, 01605, United States
Fallon Clinic, Inc.
Worcester, Massachusetts, 01605, United States
Cadillac Clinical Research, LLC, located at Great Lakes Family Care
Cadillac, Michigan, 49601, United States
Arthritis and Osteoporosis Treatment and Research Center
Flowood, Mississippi, 39232, United States
Planters Clinic
Port Gibson, Mississippi, 39150, United States
North Mississippi Medical Center, Inc.
Tupelo, Mississippi, 38801, United States
Mercy Medical Group/Woodlake Research
Clarkson Valley, Missouri, 63011, United States
Dynamic Clinical Research, Inc.
Kansas City, Missouri, 64114, United States
Joan Prouty Moore, MD
Kansas City, Missouri, 64114, United States
Orthopaedic and Occupational Medicine
Kansas City, Missouri, 64114, United States
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, 64114, United States
Affiliated Clinical Research, Inc.
Las Vegas, Nevada, 89106, United States
Office of Michael Mall, M.D.
Las Vegas, Nevada, 89109, United States
Nevada Imaging Centers
Las Vegas, Nevada, 89117, United States
Nevada Imaging Centers
Las Vegas, Nevada, 89118, United States
Office of Danka Michaels, MD
Las Vegas, Nevada, 89128, United States
Office of Stephen H. Miller, MD
Las Vegas, Nevada, 89144, United States
Regional Clinical Research, Inc.
Endwell, New York, 13760, United States
NYU Hospital for Joint Diseases
New York, New York, 10003, United States
VirtualScopics, Inc.
Rochester, New York, 14625, United States
Crouse Medical Practice, PLLC d/b/a Internist Associates of Central New York
Syracuse, New York, 13210, United States
Kernodle Clinic Inc.
Burlington, North Carolina, 27215, United States
Southeastern Radiology
Greensboro, North Carolina, 27407, United States
PharmQuest
Greensboro, North Carolina, 27408, United States
Research Institute of the Carolinas, PLLC
Mooresville, North Carolina, 28117, United States
PMG Research of Salisbury
Salisbury, North Carolina, 28144, United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625, United States
Carolina Arthritis Associates, PA
Wilmington, North Carolina, 28401, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
Internal Medicine Associates
Fargo, North Dakota, 58103, United States
Lillestol Research, LLC
Fargo, North Dakota, 58103, United States
Advantage Diagnostics
Beachwood, Ohio, 44122, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, 43213, United States
Optimed Research, LLC
Columbus, Ohio, 43235, United States
Lake Health Lyndhurst Clinic
Lyndhurst, Ohio, 44124, United States
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, 18015, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
BioImaging Technologies, Inc.
Newtown, Pennsylvania, 18940, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860, United States
Rheumatology Associates
Charleston, South Carolina, 29407, United States
Radiant Research, Inc.
Greer, South Carolina, 29651, United States
Parkway Medical Group
Fayetteville, Tennessee, 37334, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
D. Matthew Sellers MD PC
Knoxville, Tennessee, 37920, United States
Southwind Medical Specialists
Memphis, Tennessee, 38125, United States
Baylor Research Institute
Dallas, Texas, 75231, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217, United States
South Texas Radiology Imaging Center
San Antonio, Texas, 78217, United States
Oakwell Clinical Research, LLC
San Antonio, Texas, 78218, United States
Pivotal Research Centers
Midvale, Utah, 84047, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502, United States
National Clinical Research, Incorporated
Richmond, Virginia, 23294, United States
Advanced Pain Management
Virginia Beach, Virginia, 23454, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, 98405, United States
Clinical Investigation Specialists, Inc.
Kenosha, Wisconsin, 53142, United States
OMI - Organización Médica de Investigación
Buenos Aires, C1013AAR, Argentina
Saint Dennis Medical Group S.A.
Buenos Aires, C1034ACO, Argentina
Investigaciones Reumatológicas y Osteológicas S.R.L.
Buenos Aires, C1114AAH, Argentina
Instituto Médico Especializado (IME)
Buenos Aires, C1405BCH, Argentina
IMAI Research
Buenos Aires, C1425AWC, Argentina
Menzies Research Institute
Hobart, Tasmania, 7000, Australia
Cliniques Universitaires St Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Gasthuisberg / Rheumatology
Leuven, 3000, Belgium
Rheumatology Research Associates Ltd.
Edmonton, Alberta, T5M 0H4, Canada
Nexus Clinic Research
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
The Arthritis Program Research Group Inc.
Newmarket, Ontario, L3Y 3R7, Canada
Centre de Rhumatologie St-Louis
Sainte-Foy, Quebec, G1W 4R4, Canada
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91, Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno-Židenice, 615 00, Czechia
MEDIPONT Plus, s.r.o.
České Budějovice, 370 01, Czechia
MEDIPONT, s.r.o.
České Budějovice, 370 01, Czechia
ARTMEDI UPD s r.o.
Hostivice, 253 01, Czechia
Nemocnice Na Frantisku s poliklinikou
Prague, 11000, Czechia
Revmatologicky ustav
Prague, 128 50, Czechia
Centrum pro zdravotnicke zabezpeceni sportovni reprezentace
Prague, 162 00, Czechia
Ustredni vojenska nemocnice Praha
Prague, 162 00, Czechia
MSI - Muskuloskeletalni institut
Prague, 169 00, Czechia
DC Mediscan
Praha 11 - Chodov, 148 00, Czechia
MediCentrum Praha, a.s.
Praha 11 - Chodov, 148 00, Czechia
Nemocnice Atlas, a.s.
Zlín, 760 01, Czechia
PV-Medical s.r.o.
Zlín, 760 01, Czechia
Praxis fuer Orthopaedie, Chirotherapie und Akupunktur
Bad Hersfeld, 36251, Germany
Praxis fuer Orthopaedie
Berlin, 12247, Germany
Klinische Forschung Berlin-Buch
Berlin, 13125, Germany
Praxis Dr. Thomas Jung
Deggingen, 73326, Germany
Klinische Forschung Schwerin
Schwerin, 19055, Germany
Orszagos Gerincgyogyaszati Kozpont
Budapest, 1126, Hungary
Synexus Magyarorszag Kft.
Budapest, H-1036, Hungary
Heves Megyei Onkormanyzat Markhot Ferenc Korhaz
Eger, 3300, Hungary
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz, Reumatologia
Gyula, 5700, Hungary
Selye Janos Korhaz, Reumatologiai Szakrendelo
Komárom, 2900, Hungary
MAV Korhaz es Rendelointezet
Szolnok, H-5000, Hungary
Veszprem Megyei Onkormanyzat Csolnoky Ferenc Korhaz-Rendelointezet
Veszprém, H-8200, Hungary
Azienda Sanitaria Genovese, Ospedale La Colletta, Dipartimento Apparato Locomotore
Arenzano, 16011, Italy
Presidio Ospedaliero Augusto Murri, Reparto di Reumatologia
Jesi (Ancona), 60035, Italy
Ospedale Luigi Sacco, Azienda Ospedaliera Polo Universitario Unita' Operativa di Reumatologia
Milan, 20157, Italy
Clínica San Felipe
Lima, Lima Province, L-11, Peru
Hospital Nacional "Edgardo Rebagliati Martins" - Essalud
Lima, Lima Province, L-11, Peru
Instituto Peruano del Hueso y la Articulación SAC.
Lima, Lima Province, L-27, Peru
Hospital Maria Auxiliadora
Lima, Lima Province, L-29, Peru
Centro Medico Corpac
Lima, Lima Province, Lima-27, Peru
Centro Empresarial - Altavista Polo 4
Santiago de Surco, Lima region, Lima 33, Peru
Instituto de Ginecologia y Reproducción & Cirugia Minimamente Invasiva
Santiago de Surco, Lima region, Lima 33, Peru
Hospital Nacional "Alberto Sabogal Sologuren" - Essalud
Callao, Provincia Constitucional del Callao, Callao-02, Peru
NSZOZ "MEDICUS II" S.C. Irena Klimczak, Malgorzata Klimczak, Jerzy Klimczak
Cieszyn, 43-400, Poland
"SYNEXUS SCM" Sp. z o.o.
Wroclaw, 50-088, Poland
Katedra i Klinika Ortopedii i Traumatologii Narzadu Ruchu
Wroclaw, 50-556, Poland
Russian State Medical University, Moscow Faculty, City Clinical Hospital #4
Moscow, 115093, Russia
Institute of Rheumatology
Moscow, 115522, Russia
City Alexandrovskaya Hospital
Saint Petersburg, 193312, Russia
L.G. Sokolov Clinical Hospital #122 of Federal Medical-Biology Agency of Russia, Central Polyclinic
Saint Petersburg, 194291, Russia
Research Institute of Traumatology and Orthopedy Named After R. R. Vredena
Saint Petersburg, 195427, Russia
V. Interna klinika FN a LF UK
Bratislava, 826 06, Slovakia
Ivan Ujvari
Bratislava, Slovakia
Narodny ustav reumatickych chorob
Piešťany, 921 12, Slovakia
Hospital Ntra. Sra. de La Esperanza
Santiago de Compostela, A Coruña, 15705, Spain
Hospital General Universitario de Guadalajara
Guadalajara, Guadalajara, 19002, Spain
Hospital Nuestra Señora de Valme
Seville, Sevilla, 41014, Spain
Related Publications (1)
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.
PMID: 23144445DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2007
First Posted
November 30, 2007
Study Start
November 1, 2007
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
December 30, 2016
Results First Posted
December 30, 2016
Record last verified: 2016-11