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



Status:Completed
Healthy:No
Age Range:30 - 70
Updated:3/29/2019
Start Date:March 2015
End Date:February 2018

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A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)

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


Inclusion Criteria:

- Patients with lumbar disc herniation (L1-L2, L2-L3, L3-L4, 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 Femoral Nerve Stretching (FNS) test for L1-L2,
L2-L3, or L3-L4 and Straight Leg Raising (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 undergone lumbar operation, or lumbar percutaneous nucleotomy or
lumbar intradiscal therapies
We found this trial at
32
sites
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Plano, TX
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Bloomington, IL
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Carmel, IN
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Charleston, South Carolina 29412
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Charleston, SC
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Clermont, FL
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Eichstätt,
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Eugene, OR
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Gold River, CA
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Greenwood Village, Colorado 80111
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Greenwood Village, CO
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Hartsdale, NY
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Hialeah, FL
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Jacksonville, FL
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Laguna Hills, CA
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Los Gatos, CA
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Marietta, GA
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Miami, FL
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Miami, FL
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Miami Gardens, FL
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Mobile, AL
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Naples, FL
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Newnan, GA
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Phoenix, AZ
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Pinellas Park, FL
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Riverside, CA
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Saint Peters, MO
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Saint Petersburg, Florida 33713
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Saint Petersburg, FL
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Sandy, UT
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Sarasota, FL
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Shreveport, LA
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South Miami, FL
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Temecula, CA
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Winter Park, FL
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