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

Phase 3

Withdrawn

• Conditions: Knee Osteoarthritis
• Interventions: Drug: SD-6010; Drug: Placebo

• Registration Number: NCT01438918
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-20
• Study First Posted: 2011-09-22
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-25
• Study Start: 2012-03
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mg	SD-6010	Low dose active comparator
Placebo	Placebo	Placebo comparator to be used for control purposes
200 mg	SD-6010	High dose active comparator

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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