CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,011 enrolled
Drug / intervention
Condoliasedrug
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/NCT02421601
NCT02421601Phase 3Completed
CompareCT.gov

A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)

Seikagaku Corporation·interventional·Posted Apr 20, 2015·Updated Mar 23, 2023

In Brief

A Phase 3 clinical trial evaluating Condoliase for Intervertebral Disc Disease and Lumbar Disc Disease. Completed, enrolled 1,011 participants across 48 sites in 4 countries.

Detailed Summary

The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntervertebral Disc Disease, Lumbar Disc Disease
CountriesGermany, Romania, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 20, 2015
Enrollment StartMar 1, 2015
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.2 years ago

Interventions

Condoliasedrug

1.25 U, intradiscal injection, one time