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

Pfizer

Status and phase: Withdrawn; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Drug: SD-6010; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01438918

A6171017

Details and patient eligibility

About

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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

200 mg

Active Comparator group

Description:

High dose active comparator

Treatment:

Drug: SD-6010

Drug: SD-6010

50 mg

Active Comparator group

Description:

Low dose active comparator

Treatment:

Drug: SD-6010

Drug: SD-6010

Placebo

Placebo Comparator group

Description:

Placebo comparator to be used for control purposes

Treatment:

Drug: Placebo