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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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200 mg

High dose active comparator

Group Type ACTIVE_COMPARATOR

SD-6010

Intervention Type DRUG

200 mg tablets once a day for 2 years

50 mg

Low dose active comparator

Group Type ACTIVE_COMPARATOR

SD-6010

Intervention Type DRUG

50 mg tablets once a day for 2 years

Placebo

Placebo comparator to be used for control purposes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets once a day for 2 years

Interventions

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SD-6010

200 mg tablets once a day for 2 years

Intervention Type DRUG

SD-6010

50 mg tablets once a day for 2 years

Intervention Type DRUG

Placebo

Placebo tablets once a day for 2 years

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No