SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

Lumbar Vertebra Hernia Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634946
• Other study ID #: 6603/1021
• Secondary ID: 6603/1021
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2008
• Est. completion date: August 2010

Study information

• Verified date: March 2023
• Source: Seikagaku Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: August 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 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 lower leg

• Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Vertebra Hernia

Intervention

Drug:
• SI-6603
SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
• Placebo
Placebo is administrated into the nucleus pulposus of an intervertebral disc.

Locations

Country	Name	City	State
Japan	Chubu Area	Chubu
Japan	Chugoku Area	Chugoku
Japan	Hokkaido Area	Hokkaido
Japan	Kansai Area	Kansai
Japan	Kanto Area	Kanto
Japan	Kyushu Area	Kyushu
Japan	Shikoku Area	Shikoku
Japan	Tohoku Area	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Seikagaku Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in leg pain from baseline.		13 weeks
Secondary	The leg pain		At each assessment time point