Summary

for people ages 30-70 (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

Official Title

A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)

Keywords

Lumbar Disc Herniation Radiculopathy Sciatica Intradiscal injection Chemonucleolysis Hernia

Eligibility

You can join if…

Open to people ages 30-70

  • Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root.
  • Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less.
  • Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy
  • Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment.

You CAN'T join if...

  • Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
  • Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine.
  • Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization.
  • Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization.
  • Subjects with a body mass index (BMI) ≥40.
  • Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.

Locations

  • University of California San Diego - Center for Pain Medicine accepting new patients
    La Jolla California 92093 United States
  • The Helm Center for Pain Management accepting new patients
    Laguna Woods California 92637 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seikagaku Corporation
Links
Study website
ID
NCT03607838
Phase
Phase 3
Study Type
Interventional
Last Updated