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
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
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
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