Trials / Completed
CompletedNCT03607838
SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 352 (actual)
- Sponsor
- Seikagaku Corporation · Industry
- Sex
- All
- Age
- 30 Years – 70 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-11-07
- Primary completion
- 2022-08-03
- Completion
- 2023-03-21
- First posted
- 2018-07-31
- Last updated
- 2025-07-24
- Results posted
- 2025-07-11
Locations
67 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03607838. Inclusion in this directory is not an endorsement.