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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00565812




Registration number
NCT00565812
Ethics application status
Date submitted
29/11/2007
Date registered
30/11/2007
Date last updated
30/12/2016

Titles & IDs
Public title
A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
Scientific 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
Secondary ID [1] 0 0
2007-001457-26
Secondary ID [2] 0 0
A6171016
Universal Trial Number (UTN)
Trial acronym
ITIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SD-6010
Treatment: Drugs - SD-6010
Treatment: Drugs - Placebo

Active comparator: 200 mg - High dose active comparator

Active comparator: 50 mg - Low dose active comparator

Placebo comparator: Placebo - Placebo comparator to be used for control purposes


Treatment: Drugs: SD-6010
200 mg tablets once a day for 2 years

Treatment: Drugs: SD-6010
50 mg tablets once a day for 2 years

Treatment: Drugs: Placebo
Placebo tablets once a day for 2 years
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Progression of Joint Space Narrowing
Timepoint [1] 0 0
Baseline up to Month 24
Primary outcome [2] 0 0
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2
Timepoint [2] 0 0
Baseline up to Month 24
Primary outcome [3] 0 0
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3
Timepoint [3] 0 0
Baseline up to Month 24
Secondary outcome [1] 0 0
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24
Timepoint [1] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [2] 0 0
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [2] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [3] 0 0
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [3] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [4] 0 0
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [4] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [5] 0 0
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24
Timepoint [5] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [6] 0 0
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Timepoint [6] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [7] 0 0
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24
Timepoint [7] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [8] 0 0
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24
Timepoint [8] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [9] 0 0
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24
Timepoint [9] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [10] 0 0
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [10] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [11] 0 0
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24
Timepoint [11] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [12] 0 0
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24
Timepoint [12] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Baseline, Month 3, 6, 12, 18, 24
Secondary outcome [14] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24
Timepoint [14] 0 0
Baseline, Month 12, 24
Secondary outcome [15] 0 0
Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24
Timepoint [15] 0 0
Baseline, Month 12, 24
Secondary outcome [16] 0 0
Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24
Timepoint [16] 0 0
Baseline, Month 12, 24
Secondary outcome [17] 0 0
Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24
Timepoint [17] 0 0
Baseline, Month 12, 24
Secondary outcome [18] 0 0
Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24
Timepoint [18] 0 0
Baseline, Month 12, 24
Secondary outcome [19] 0 0
Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24
Timepoint [19] 0 0
Baseline, Month 12, 24
Secondary outcome [20] 0 0
Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24
Timepoint [20] 0 0
Baseline, Month 12, 24
Secondary outcome [21] 0 0
Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24
Timepoint [21] 0 0
Baseline, Month 12, 24
Secondary outcome [22] 0 0
Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24
Timepoint [22] 0 0
Baseline, Month 12, 24
Secondary outcome [23] 0 0
Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24
Timepoint [23] 0 0
Baseline, Month 12, 24
Secondary outcome [24] 0 0
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score
Timepoint [24] 0 0
Baseline, Month 12, 24
Secondary outcome [25] 0 0
Number of Participants With EuroQoL-5D Self-Care Domain Score
Timepoint [25] 0 0
Baseline, Month 12, 24
Secondary outcome [26] 0 0
Number of Participants With EuroQoL-5D Usual Activity Domain Score
Timepoint [26] 0 0
Baseline, Month 12, 24
Secondary outcome [27] 0 0
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score
Timepoint [27] 0 0
Baseline, Month 12, 24
Secondary outcome [28] 0 0
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score
Timepoint [28] 0 0
Baseline, Month 12, 24
Secondary outcome [29] 0 0
EuroQoL-5D Visual Analog Scale Score
Timepoint [29] 0 0
Baseline, Month 12, 24
Secondary outcome [30] 0 0
Number of Participants With Increase in Total Analgesic Medication Use
Timepoint [30] 0 0
Month 12, 24
Secondary outcome [31] 0 0
Number of Participants With Decrease in Total Analgesic Medication Use
Timepoint [31] 0 0
Month 12, 24
Secondary outcome [32] 0 0
Patient Global Impression of Change Score
Timepoint [32] 0 0
Month 24
Secondary outcome [33] 0 0
Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index
Timepoint [33] 0 0
Month 24
Secondary outcome [34] 0 0
Number of Participants With Joint Space Narrowing Progression
Timepoint [34] 0 0
Month 24
Secondary outcome [35] 0 0
Number of Participants Applicable for Virtual Joint Replacement
Timepoint [35] 0 0
Month 24

Eligibility
Key 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
Minimum age
40 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
1457
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 0 0
Menzies Research Institute - Hobart
Recruitment postcode(s) [1] 0 0
7000 - Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Utah
Country [32] 0 0
United States of America
State/province [32] 0 0
Virginia
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
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Buenos Aires
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Belgium
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Bruxelles
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Belgium
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Leuven
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Canada
State/province [38] 0 0
Alberta
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Canada
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Newfoundland and Labrador
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
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Canada
State/province [41] 0 0
Quebec
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Czech Republic
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Brno - Zidenice
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Czech Republic
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Brno
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Czech Republic
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Ceske Budejovice
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Hostivice
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Praha 11 - Chodov
Country [47] 0 0
Czech Republic
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Praha 1
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Czech Republic
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Praha 2
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Czech Republic
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Praha 6
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Czech Republic
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Zlin
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Germany
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Bad Hersfeld
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Germany
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Berlin
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Germany
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Deggingen
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Germany
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Schwerin
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Hungary
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Budapest
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Hungary
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Eger
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Hungary
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Gyula
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Hungary
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Komarom
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Hungary
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Szolnok
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Hungary
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Veszprem
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Italy
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Arenzano
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Italy
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Jesi (Ancona)
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Italy
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Milano
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Peru
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Lima
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Peru
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Callao
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Poland
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Cieszyn
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Poland
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Wroclaw
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Slovakia
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Bratislava
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Slovakia
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Piestany
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Spain
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A Coruña
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Spain
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Guadalajara
Country [74] 0 0
Spain
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Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00565812
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00565812