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NCT01941563 Clinical Trial

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

Lumbar Disc Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01941563
Other study ID # 6603/1131
Secondary ID 6603/1131
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2013
Est. completion date August 2017

Study information
Verified date March 2023
Source Seikagaku Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 385
Est. completion date August 2017
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 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 received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent. - Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Condoliase
1.25U, intradiscal injection, one time
• placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Seikagaku Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Leg pain Assessed by Visual Analog Scale (VAS) 13 weeks
Secondary Responder rate evaluation Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure 13 weeks
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