Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 6603/1131 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of SI-6603 (condoliase) in patients with lumbar disc herniation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SI-6603 | Experimental | SI-6603 is administrated into the nucleus pulposus of the intervertebral disc |
|
| Control | Sham Comparator | Sham injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Condoliase | Drug | 1.25U, intradiscal injection, one time |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Leg pain | Assessed by Visual Analog Scale (VAS) | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Responder rate evaluation | Assessed by leg pain (VAS), Oswestry Disability Index disability questionnaire, neurologic status (motor, sensory, reflexes), and no treatment failure | 13 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Gold River |
| California |
| United States |
| Laguna Hills | California | United States |
| Los Gatos | California | United States |
| Murrieta | California | United States |
| Riverside | California | United States |
| Denver | Colorado | United States |
| Hialeah | Florida | United States |
| Jacksonville | Florida | United States |
| Merritt Island | Florida | United States |
| Miami | Florida | United States |
| Naples | Florida | United States |
| North Miami Beach | Florida | United States |
| Orlando | Florida | United States |
| Pinellas Park | Florida | United States |
| Sarasota | Florida | United States |
| St. Petersburg | Florida | United States |
| Sunrise | Florida | United States |
| Winter Park | Florida | United States |
| Marietta | Georgia | United States |
| Newnan | Georgia | United States |
| Bloomington | Illinois | United States |
| Carmel | Indiana | United States |
| Shreveport | Louisiana | United States |
| City of Saint Peters | Missouri | United States |
| Hartsdale | New York | United States |
| Eugene | Oregon | United States |
| State College | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Dallas | Texas | United States |
| Sandy City | Utah | United States |
| Edmonds | Washington | United States |
| ID | Term |
|---|---|
| C535531 | Intervertebral disc disease |
Not provided
Not provided
Not provided