Phase 3 Completed N=991 Treatment

A Study of SI-6603 in Patients With Lumbar Disc Herniation

Intervertebral Disc Disease · Lumbar Disc Disease

Source: ClinicalTrials.gov NCT02421601 ↗

Enrolled (actual)

991

Serious AEs

3.6%

Results posted

Nov 2021

Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAE) — 615 Participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

The purpose of this study is to evaluate the safety and efficacy of SI-6603(Condoliase) in patients with lumbar disc herniation.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.