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Completed

NCT Number: NCT01941563

A Study of SI-6603 in Patients With Lumbar Disc Herniation

The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.

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Key information

Conditions

Intervertebral Disc Disease Lumbar Disc Disease

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 leg.
  • Patients with no improvement from conservative treatment

Exclusion criteria

  • Patients who have 2 or more lumbar disc herniations as assessed by MRI.
  • Patients in whom a rupture into the posterior longitudinal ligament is identified by MRI.
  • Patients who have received spinal injection, epidural injection, nerve block within 3 weeks prior to the time of informed consent.
  • Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or lumbar intradiscal therapies

Treatment and study plan

Condoliase

Drug

1.25U, intradiscal injection, one time

Placebo

Drug

Primary outcomes

  1. Leg pain

    Time frame: 13 weeks

    Assessed by Visual Analog Scale (VAS)

Secondary outcomes

  1. Responder rate evaluation

    Time frame: 13 weeks

    Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure

Sponsors and collaborators

Lead sponsor

Seikagaku Corporation

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Sep 13, 2013
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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