Overview

This trial is active, not recruiting.

Conditions intervertebral disc disease, lumbar disc disease
Treatments condoliase, placebo
Phase phase 3
Sponsor Seikagaku Corporation
Start date September 2013
End date November 2015
Trial size 360 participants
Trial identifier NCT01941563, 6603/1131

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
condoliase
1.25U, intradiscal injection, one time
(Sham Comparator)
Sham injection
placebo

Primary Outcomes

Measure
Leg pain
time frame: 13 weeks

Secondary Outcomes

Measure
Responder rate evaluation
time frame: 13 weeks

Eligibility Criteria

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

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

Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Seikagaku Corporation.