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

NCT01438918 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2012-01-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SD-6010

200 mg tablets once a day for 2 years

DRUG

SD-6010

50 mg tablets once a day for 2 years

DRUG

Placebo

Placebo tablets once a day for 2 years

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01438918 on ClinicalTrials.gov