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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Seikagaku Corporation
Sponsor:
Information provided by (Responsible Party):
Seikagaku Corporation
ClinicalTrials.gov Identifier:
NCT01941563
First received: September 4, 2013
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Intervertebral Disc Disease
Lumbar Disc Disease
Drug: Condoliase
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seikagaku Corporation:

Primary Outcome Measures:
  • Leg pain [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Assessed by Visual Analog Scale (VAS)


Secondary Outcome Measures:
  • Responder rate evaluation [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure


Estimated Enrollment: 360
Study Start Date: September 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01941563

Contacts
Contact: Ryoichi Takagi +81-3-5220-8948 si6603.1131ctg@seikagaku.co.jp

  Show 34 Study Locations
Sponsors and Collaborators
Seikagaku Corporation
  More Information

No publications provided

Responsible Party: Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT01941563     History of Changes
Other Study ID Numbers: 6603/1131, 6603/1131
Study First Received: September 4, 2013
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014