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

NCT01941563 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2023-03-23

No results posted yet for this study

Summary

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

Conditions

  • Intervertebral Disc Disease
  • Lumbar Disc Disease

Interventions

DRUG

Condoliase

1.25U, intradiscal injection, one time

DRUG

placebo

Sponsors & Collaborators

  • Seikagaku Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-11-30
Completion
2017-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01941563 on ClinicalTrials.gov