A Long-term, Confirmatory, Phase 3, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study To Investigate The Safety And Efficacy Of Orally Administered Sd-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee

Pfizer0 sitesMarch 2012

ConditionsKnee Osteoarthritis

InterventionsSD-6010 Placebo

DrugsSD-6010 Placebo

Overview

Phase: Phase 3
Intervention: SD-6010
Conditions: Knee Osteoarthritis
Sponsor: Pfizer
Primary Endpoint: To assess the progression rate of joint space narrowing in the study knee of subjects with knee OA over a 24-month period
Status: Withdrawn
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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). 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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

December 2015

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

200 mg

High dose active comparator

Intervention: SD-6010

50 mg

Low dose active comparator

Intervention: SD-6010

Placebo

Placebo comparator to be used for control purposes

Intervention: Placebo

Outcomes

Primary Outcomes

To assess the progression rate of joint space narrowing in the study knee of subjects with knee OA over a 24-month period

Time Frame: 24 months

Secondary Outcomes

Clinical benefit of SD 6010 will be measured from changes in response from baseline to 24 months in 7 patient reported outcomes (PRO), including, but not limited to, WOMAC, pain VAS, ICOAP, KOOS.(24 months)
Total analgesic medication burden for OA in the study knee will be compared back to baseline of an increased, sustained use of standard background and/or rescue medication for more than 30 days as measured at the Month 12 and 24 visits(24 months)
Safety: Change from baseline to M24 in vital signs (blood pressure, heart rate) measurements will be assessed(24 months)
Safety: Change from baseline to M24 in ECG abnormalities(24 months)
Safety: In a subset of subjects: Change from baseline on average as assessed by 24-h ambulatory blood pressure monitoring (ABPM) at months 3 and 6(6 months)