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.
  • Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 35 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 10 days prior to randomization.
  • Subjects who have taken extended- or controlled-release opioids within the past 6 months, subjects who average more than 2 doses per week of immediate-release opioids, or subjects who use cannabis for relief of pain
  • Subjects with a body mass index (BMI) ≥35.
  • 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
http://www.thediscoverystudy.com/
ID
NCT03607838
Phase
Phase 3
Study Type
Interventional
Last Updated