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


Tracking Information

Start Date  ICMJEDecember 2007
Estimated Primary Completion DateJanuary 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)		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 ]
Original Primary Outcome Measures ICMJE 
 (submitted: November 29, 2007)		Assessing the progression rate of joint space narrowing in the study knee of women diagnosed with knee OA over a 24-month period.
Change HistoryComplete list of historical versions of study NCT00565812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: June 16, 2008)
  • 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 ]
Original Secondary Outcome Measures ICMJE 
 (submitted: November 29, 2007)
  • 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

Descriptive Information

Brief Title  ICMJEA Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
Official Title  ICMJEA 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 
Study PhasePhase II, Phase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEOsteoarthritis
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 / Comparison Groups
  • 200 mg: Active Comparator
    High dose active comparator
    Intervention: Drug: SD-6010
  • 50 mg: Active Comparator
    Low dose active comparator
    Intervention: Drug: SD-6010
  • Placebo: Placebo Comparator
    Placebo comparator to be used for control purposes
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE1400
Estimated Completion DateJanuary 2012
Estimated Primary Completion DateJanuary 2012   (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
GenderBoth
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Canada,   Czech Republic,   Germany,   Hungary,   Italy,   Peru,   Poland,   Russian Federation,   Slovakia,   Spain

Administrative Information

NCT ID  ICMJENCT00565812
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA6171016
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer