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Phoenix, Arizona

  • Lumbar Disc Disease

Purpose:

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


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


Study is Available At:


Original ID:

6603/1132


NCT ID:

NCT02421601


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

30 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Seikagaku Corporation


Oversight Authority:

  • United States: Food and Drug Administration
  • Spain: Spanish Agency of Medicines


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

1011


Enrollment Type:

Actual


Study Dates

Start Date:March 2015
Completion Date:February 2018
Completion Type:Actual
Primary Completion Date:February 2018
Primary Completion Type:Actual
Verification Date:March 2019
Last Changed Date:March 20, 2019
First Received Date:April 6, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Leg pain as assessed by a Visual Analog Scale (VAS)
Time Frame:26 weeks
Safety Issues:False
Description:Assessed by a Visual Analog Scale (VAS)
Outcome Type:Primary Outcome
Measure:Evaluate the safety of a single-dose intervertebral disc injection of SI-6603 in patients with lumbar disc herniation.
Time Frame:26 weeks
Safety Issues:False
Description:The occurence of Adverse Events as a measure to evaluate the safety of a single-dose of SI-6603

Study Interventions

Intervention Type:Drug
Name:Condoliase
Description:1.25 U, intradiscal injection, one time
Arm Name:SI-6603

Study Arms

Study Arm Type:Experimental
Arm Name:SI-6603
Description:SI-6603: SI-6603 is administrated into the nucleus pulposus of the intervertebral disc

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Seikagaku Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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