SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study) (NCT03607838) | Clinical Trial Compass
CompletedPhase 3
SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)
United States352 participantsStarted 2018-11-07
Plain-language 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)
Who can participate
Age range30 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Change From Baseline to Week 13 in Average Worst Leg Pain Score During the Past 24 Hours Over the Previous 7 Days