Phase 3
N=991
A Study of SI-6603 in Patients With Lumbar Disc Herniation
Intervertebral Disc Disease · Lumbar Disc Disease
Bottom Line
View on ClinicalTrials.gov: NCT02421601 ↗Enrolled (actual)
991
Serious AEs
3.6%
Results posted
Nov 2021
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAE) — 615 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Condoliase (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Seikagaku Corporation
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAE) |
615 | — |
| SECONDARY Worst Leg Pain as Assessed by Visual Analog Scale (VAS) |
28.6 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.
Eligibility Criteria
Inclusion Criteria
- Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, L4-L5 or L5-S1) as assessed by MRI and clinical symptoms corresponding to position of the impaired nerve root.
- Patients assessed as positive in the Femoral Nerve Stretching (FNS) test for L1-L2, L2-L3, or L3-L4 and Straight Leg Raising (SLR) test.
- Patients with sciatica in either leg.
- Patients with no improvement from conservative treatment
Exclusion Criteria
- Patients who have 2 or more lumbar disc herniations as assessed by MRI.
- Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.
- Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies
Data sourced from ClinicalTrials.gov (NCT02421601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.