Clinical trial

An Open Label, Non-randomized Dose-escalation Study to Assess Safety and Tolerability of SI-6603 in Patients With Lumbar Disc Herniation (Phase II Study)

NCT01282606

Name

6603/1121

Description

The purpose of this study is to evaluate the safety of SI-6603 in lumbar disc herniation patients.

Trial arms

Trial start

2007-12-01

Estimated PCD

2012-08-01

Phase

Early phase I

Treatment

SI-6603

SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.

Arms:

Drug I: SI-6603 (Low), Drug II: SI-6603 (Middle), Drug III: SI-6603 (High)

Size

Primary endpoint

Adverse events

52 weeks

Eligibility criteria

Inclusion Criteria: * Patients with lumbar disc herniation (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 SLR test. * Patients with sciatica in either lower leg. * Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block. Exclusion Criteria: * Patients who have 2 or more lumbar disc herniations as assessed by MRI. * Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI. * Patients who have received nerve block within 3 weeks before screening. * Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

Updated at

2023-03-23

1 organization

1 product

1 indication

Organization

Seikagaku

Product

SI-6603

Indication

Lumbar Disc Herniation