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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

 
Study IDNCT00565812
StatusRecruiting
Phase2-3
SourceClinicalTrials.gov
StartedDec 1 2007
Last UpdatedJan 27 2010
Estimated CompletionJan 27 2010
  
About this clinical study

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.

Condition / Disease

Osteoarthritis

Therapy

SD-6010
Placebo

Study Outcomes

  • Assessing the progression rate of joint space narrowing in the study knee of subjects diagnosed with knee OA over a 24-month period.
  • Assessing the safety and tolerability of multiple doses of SD-6010 administered long-term in subjects diagnosed with knee OA;
  • Assessing the clinical benefit of multiple doses of SD-6010 in subjects diagnosed with knee OA

Sponsors

Primary SponsorPfizer
 

Enrollment

Overview

Gendermale, female
 
Target Enrollment1400
 
Recruiting Healthy VolunteersNo

Locations

Pfizer Investigational SiteWashingtonDC2 mi

Criteria


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

    • Contact

    Overall Contact

    Pfizer CT.gov Call Center - 1-800-718-1021

    Investigators

    Pfizer CT.gov Call CenterStudy Director
     

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