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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01941563
Recruitment Status : Active, not recruiting
First Posted : September 13, 2013
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2013
Primary Completion Date : November 2015
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

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
More Information

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: March 14, 2017
Last Verified: March 2017

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