Overview

X-Ray Study Investigating The Safety And Efficacy Of SD-6010 In Subjects With Osteoarthritis Of The Knee

Status:
Withdrawn
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
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). 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

Subjects aged >= 40 years Diagnosed with knee OA (ACR definition of 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