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

Last updated on December 16, 2017

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Study Location
Brookwood Internists, P.C.
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
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

- 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

NCT00565812
Pfizer
Completed
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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A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • 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
  • 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
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.
 
Completed
1457
November 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Italy,   Peru,   Poland,   Russian Federation,   Slovakia,   Spain,   United States
 
 
NCT00565812
A6171016
2007-001457-26 ( EudraCT Number )
ITIC ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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