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

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NCT00565812

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Study Location
Brookwood Internists, P.C.
Birmingham, Alabama, 35209, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- A diagnosis of any other rheumatic disease


- Current conditions in the study knee that would confound efficacy


- Selected, traditional clinical safety and laboratory parameters

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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: 200 mg
    High dose active comparator
    Intervention: Drug: SD-6010
  • Active Comparator: 50 mg
    Low dose active comparator
    Intervention: Drug: SD-6010
  • Placebo Comparator: Placebo
    Placebo comparator to be used for control purposes
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2016)		1457
Original Enrollment  ICMJE
 (submitted: November 29, 2007)		1400
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Italy,   Peru,   Poland,   Russian Federation,   Slovakia,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00565812
Other Study ID Numbers  ICMJE A6171016
2007-001457-26 ( EudraCT Number )
ITIC ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP