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SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

NCT03607838 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2025-07-24

Study results available
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Summary

This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

Conditions

  • Lumbar Disc Herniation

Interventions

DRUG

SI-6603

SI-6603 will be injected into an intervertebral disc.

DRUG

Sham injection

The injection will be performed without needle placement into an intervertebral disc.

Sponsors & Collaborators

  • Seikagaku Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2022-08-03
Completion
2023-03-21
FDA Drug
Yes

Countries

  • United States

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 NCT03607838 on ClinicalTrials.gov