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SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation

NCT00634946 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2023-03-23

No results posted yet for this study

Summary

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

Conditions

  • Lumbar Vertebra Hernia

Interventions

DRUG

SI-6603

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

DRUG

Placebo

Placebo is administrated into the nucleus pulposus of an intervertebral disc.

Sponsors & Collaborators

  • Seikagaku Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-11-30
Completion
2010-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00634946 on ClinicalTrials.gov