NCT01282606

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

January 24, 2011

Last Update Submit

March 21, 2023

Conditions

Lumbar Vertebra Hernia

Keywords

ChemonucleolysisLumbar VertebraeHernia

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    52 weeks

Secondary Outcomes (1)

  • The leg pain

    At each assessment time point

Study Arms (3)

Drug I: SI-6603 (Low)

EXPERIMENTAL
Drug: SI-6603

Drug II: SI-6603 (Middle)

EXPERIMENTAL
Drug: SI-6603

Drug III: SI-6603 (High)

EXPERIMENTAL
Drug: SI-6603

Interventions

SI-6603DRUG

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

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

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKK

Encinitas, California, 92024, United States

Location

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 25, 2011

Study Start

December 1, 2007

Primary Completion

August 1, 2012

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

US(1)