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A Study of SI-6603 in Patients With Lumbar Disc Herniation

NCT02421601 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1011

Last updated 2023-03-23

Study results available
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Summary

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

Conditions

  • Intervertebral Disc Disease
  • Lumbar Disc Disease

Interventions

DRUG

Condoliase

1.25 U, intradiscal injection, one time

Sponsors & Collaborators

  • Seikagaku Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States
  • Germany
  • Romania
  • Spain

Study Locations

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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 NCT02421601 on ClinicalTrials.gov