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Trial record 2 of 14 for:    Seikagaku

SI-6603 (Condoliase) Study for Lumbar Disc Herniation

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ClinicalTrials.gov Identifier: NCT03607838
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Seikagaku Corporation

Brief 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)

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Drug: SI-6603 Drug: Sham injection Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: SI-6603 Drug: SI-6603
SI-6603 will be injected into an intervertebral disc.

Sham Comparator: Sham injection Drug: Sham injection
The injection will be performed without needle placement into an intervertebral disc.




Primary Outcome Measures :
  1. Average worst leg pain score during the past 24 hours over the previous 7 days [ Time Frame: 13 weeks ]
    Assessed by 100 mm Visual Analog Scale (VAS)


Secondary Outcome Measures :
  1. Average worst leg pain score during the past 24 hours over the previous 7 days [ Time Frame: 52 weeks ]
    Assessed by 100 mm Visual Analog Scale (VAS)

  2. Herniation volume assessed by MRI [ Time Frame: 13 weeks ]
  3. Oswestry Disability Index (ODI) score [ Time Frame: 13 weeks ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03607838


Contacts
Contact: Subject Well (for patients) 855-628-1646 skk-kcds@trialhero.com
Contact: Kyoichi Osano (for overall study) +81-3-5220-8948 reply@seikagaku.co.jp

  Show 28 Study Locations
Sponsors and Collaborators
Seikagaku Corporation

Responsible Party: Seikagaku Corporation
ClinicalTrials.gov Identifier: NCT03607838     History of Changes
Other Study ID Numbers: 6603 /1133
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seikagaku Corporation:
Lumbar disc herniation
Radiculopathy
Sciatica
Intradiscal injection
Chemonucleolysis

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical