CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,457 enrolled
Drug / intervention
SD-6010 +2 moredrug
Likely dose
SD-6010 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00565812
NCT00565812Phase 2Completed
CompareCT.gov

A Long-Term, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Radiographic Study To Investigate The Safety And Efficacy Of Orally Administered SD-6010 In Subjects With Symptomatic Osteoarthritis Of The Knee

Pfizer·interventional·Posted Nov 30, 2007·Updated Dec 30, 2016

In Brief

A Phase 2 clinical trial evaluating SD-6010 and Placebo for Osteoarthritis. Completed, enrolled 1,457 participants across 183 sites in 14 countries.

Detailed 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), in overweight and obese subjects with knee osteoarthritis. 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesArgentina, Australia, Belgium, Canada, Czechia, Germany, Hungary, Italy, Peru, Poland, Russia, Slovakia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 30, 2007
Enrollment StartNov 1, 2007
Primary CompletionOct 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.6 years ago

Interventions

SD-6010drug

200 mg tablets once a day for 2 years

SD-6010drug

50 mg tablets once a day for 2 years

Placebodrug

Placebo tablets once a day for 2 years