This trial is active, not recruiting.

Conditions intervertebral disc disease, lumbar disc disease
Treatment condoliase
Phase phase 3
Sponsor Seikagaku Corporation
Start date March 2015
End date March 2017
Trial size 1000 participants
Trial identifier NCT02421601, 6603/1132


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
1.25 U, intradiscal injection, one time

Primary Outcomes

Evaluate the safety of a single-dose intervertebral disc injection of SI-6603 in patients with lumbar disc herniation.
time frame: 26 weeks

Secondary Outcomes

Leg pain as assessed by a Visual Analog Scale (VAS)
time frame: 26 weeks

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Seikagaku Corporation.