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
1053
mi
from
Jacksonville, FL
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508
mi
from
Bloomington, IL
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645
mi
from
Carmel, IN
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Charleston, South Carolina 29412
1064
mi
from
Charleston, SC
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349
mi
from
Dallas, TX
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409
mi
from
Denver, CO
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1416
mi
from
Edmonds, WA
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1385
mi
from
Eugene, OR
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1270
mi
from
Gold River, CA
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1298
mi
from
Hartsdale, NY
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1314
mi
from
Hialeah, FL
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1150
mi
from
Laguna Hills, CA
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1150
mi
from
Laguna Hills, CA
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1321
mi
from
Los Gatos, CA
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788
mi
from
Marietta, GA
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1175
mi
from
Merritt Island, FL
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1320
mi
from
Miami, FL
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1124
mi
from
Murrieta, CA
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1231
mi
from
Naples, FL
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790
mi
from
Newnan, GA
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North Miami Beach, Florida 33162
1315
mi
from
North Miami Beach, FL
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1139
mi
from
Orlando, FL
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853
mi
from
Phoenix, AZ
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1110
mi
from
Pinellas Park, FL
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1130
mi
from
Riverside, CA
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396
mi
from
Saint Peters, MO
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Saint Petersburg, Florida 33713
1117
mi
from
Saint Petersburg, FL
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777
mi
from
Sandy, UT
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1143
mi
from
Sarasota, FL
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429
mi
from
Shreveport, LA
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State College, Pennsylvania 16801
1085
mi
from
State College, PA
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1298
mi
from
Sunrise, FL
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1140
mi
from
Winter Park, FL
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