drugset / Trial / NCT00565812

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

NCT00565812 ↗

Phase 2 Completed 1457 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2007-11
Primary completion
2011-10
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator cindunistat Small molecule 50 mg Oral
Comparator cindunistat Small molecule 200 mg Oral

Indications