At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 352 enrolled
Drug / intervention
SI-6603 +1 moredrug
Likely dose
SI-6603 intradiscal injection (specific dose not stated)AI-extracted
Key inclusion· 4
- ✓Single-level lumbar disc herniation (L4-L5, L5-S1, or L5-L6) with clear nerve root impingement on MRI and corresponding clinical symptoms
- ✓Unilateral radiculopathy/radicular leg pain for 6 weeks to 1 year duration
- ✓Positive Straight Leg Raise test (≤70°) on the ipsilateral leg only
- ✓Inadequate pain improvement despite ≥6 weeks of conservative treatment
Key exclusion· 7
- ✕Two or more lumbar disc herniations on MRI
- ✕Prior lumbar operation, percutaneous nucleotomy, or intradiscal therapies at the affected level
- ✕Spinal injection, epidural injection, nerve block, oral or injectable corticosteroids within 28 days prior to randomization
- ✕Opioids or cannabis within 7 days prior to randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.
A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)
In Brief
A Phase 3 clinical trial evaluating SI-6603 and Sham injection for Lumbar Disc Herniation. Completed, enrolled 352 participants across 67 sites.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Disc Herniation
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartNov 2018
Primary CompletionAug 2022
Study CompletionMar 2023
TodayJul 2026
First PostedJul 31, 2018
Enrollment StartNov 7, 2018
Primary CompletionAug 3, 2022
Study CompletionMar 21, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 7.9 years ago
Interventions
SI-6603drug
SI-6603 will be injected into an intervertebral disc.
Sham injectiondrug
The injection will be performed without needle placement into an intervertebral disc.