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

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ClinicalTrials.gov Identifier: NCT01941563
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Seikagaku Corporation

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

Condition or disease Intervention/treatment Phase
Intervertebral Disc Disease Lumbar Disc Disease Drug: Condoliase Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SI-6603
SI-6603 is administrated into the nucleus pulposus of the intervertebral disc
Drug: Condoliase
1.25U, intradiscal injection, one time
Sham Comparator: Control
Sham injection
Drug: placebo



Primary Outcome Measures :
  1. Leg pain [ Time Frame: 13 weeks ]
    Assessed by Visual Analog Scale (VAS)


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941563


  Show 32 Study Locations
Sponsors and Collaborators
Seikagaku Corporation

Responsible Party: Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT01941563     History of Changes
Other Study ID Numbers: 6603/1131
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Displacement
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Hernia
Pathological Conditions, Anatomical