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



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:30 - 70
Updated:8/12/2018
Start Date:September 2013
End Date:August 2017

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


Inclusion Criteria:

- Patients with lumbar disc herniation (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 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 received spinal injection, epidural injection, nerve block within 3
weeks prior to the time of informed consent.

- Patients who have undergone lumbar operation, or lumbar percutaneous nucleotomy or
lumbar intradiscal therapies
We found this trial at
33
sites
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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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Dallas, TX
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Denver, CO
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Edmonds, WA
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Eugene, OR
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Gold River, CA
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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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Laguna Hills, CA
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Los Gatos, CA
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Marietta, GA
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Merritt Island, FL
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Miami, FL
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Murrieta, CA
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Naples, FL
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Newnan, GA
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North Miami Beach, Florida 33162
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North Miami Beach, FL
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Orlando, FL
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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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State College, Pennsylvania 16801
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State College, PA
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Sunrise, FL
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Winter Park, FL
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