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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00565812
First received: November 29, 2007
Last updated: February 20, 2013
Last verified: February 2013

November 29, 2007
February 20, 2013
November 2007
November 2011   (final data collection date for primary outcome measure)
Assessing the progression rate of joint space narrowing in the study knee of subjects diagnosed with knee OA over a 24-month period. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Assessing the progression rate of joint space narrowing in the study knee of women diagnosed with knee OA over a 24-month period.
Complete list of historical versions of study NCT00565812 on ClinicalTrials.gov Archive Site
  • Assessing the safety and tolerability of multiple doses of SD-6010 administered long-term in subjects diagnosed with knee OA; [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Assessing the clinical benefit of multiple doses of SD-6010 in subjects diagnosed with knee OA [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Assessing the safety and tolerability of multiple doses of SD-6010 administered long-term in women diagnosed with knee OA;
  • Assessing the clinical benefit of multiple doses of SD-6010 in women diagnosed with knee OA
Not Provided
Not Provided
 
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
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5077
November 2011
November 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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Italy,   Peru,   Poland,   Russian Federation,   Slovakia,   Spain
 
NCT00565812
A6171016
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

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