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SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

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. Identifier: NCT03607838
Recruitment Status : Active, not recruiting
First Posted : July 31, 2018
Last Update Posted : April 29, 2022
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

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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 : July 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

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

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, Learn About Clinical Studies.

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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

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 at the affected level of lumbar spine.
  • Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 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 7 days prior to randomization.
  • Subjects with a body mass index (BMI) ≥40.
  • 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 identifier (NCT number): NCT03607838

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Sponsors and Collaborators
Seikagaku Corporation
Additional Information:
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Responsible Party: Seikagaku Corporation Identifier: NCT03607838    
Other Study ID Numbers: 6603 /1133
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: April 29, 2022
Last Verified: April 2022

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