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

Completed · Phase 3 · Has a placebo group

Conditions studied: Lumbar Disc Herniation

In brief

This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

Key facts

Study ID

NCT03607838

Run by

Seikagaku Corporation

People needed

352

Starts

2018-11-07

Expected to finish

2023-03-21

Last updated by the study team

2025-07-24

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pain Medicine Associates, Inc. — Fountain Valley, California, United States
• University of California San Diego - Center for Pain Medicine — La Jolla, California, United States
• The Helm Center for Pain Management — Laguna Woods, California, United States
• The Anand Spine Group — Los Angeles, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Samaritan Center for Medical Research — Los Gatos, California, United States
• UC Davis Spine Center — Sacramento, California, United States
• Source Healthcare — Santa Monica, California, United States
• Boulder Neurosurgical Associates — Boulder, Colorado, United States
• DBPS Research, LLC — Greenwood Village, Colorado, United States
• International Spine, Pain, and Performance Center — Washington D.C., District of Columbia, United States
• Florida Spine Institute — Clearwater, Florida, United States
• Spine and Orthopedic Center — Deerfield Beach, Florida, United States
• Deland Clinical research Unit — DeLand, Florida, United States
• Science Connections, LLC — Doral, Florida, United States
• Coastal Clinical Research — Fernandina Beach, Florida, United States
• Holy Cross Medical Group — Fort Lauderdale, Florida, United States
• Coastal Clinical Research — Jacksonville, Florida, United States
• Genoma Research Group, Inc. — Miami, Florida, United States
• Science Connections, LLC (Kendall) — Miami, Florida, United States
• AMPM Research Clinic — Miami Gardens, Florida, United States
• Pain Relief Centers — St. Petersburg, Florida, United States
• Pain Relief Centers — Sun City Center, Florida, United States
• Tampa Pain Relief Center — Tampa, Florida, United States
• Delta Clinical Research — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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