CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 379 enrolled
Drug / intervention
Gel-200 +1 moredevice
Likely dose
Not stated in 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/NCT00449696
NCT00449696Phase 3Completed
CompareCT.gov

A Multi-Center, Randomized, Double-Blind, Controlled, Parallel-Group Study of a Single Intra-Articular Injection of Gel-200 With a Single Intra-Articular Injection of Phosphate Buffered Saline (PBS) in Osteoarthritis of the Knee.

Seikagaku Corporation·interventional·Posted Mar 21, 2007·Updated Oct 7, 2011

In Brief

A Phase 3 clinical trial evaluating Gel-200 and Placebo for Osteoarthritis of the Knee. Completed, enrolled 379 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis of the Knee
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 21, 2007
Enrollment StartSep 1, 2006
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.3 years ago

Interventions

Gel-200device

Single intra-articular injection

Placebodevice

Single intra-articular injection