Clinical trial NCT02421601: A Study of SI-6603 in Patients With Lumbar Disc Herniation
Official title: A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intervertebral Disc Disease
Lumbar Disc Disease
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 1011
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
timeFrame: 26 weeks
Secondary outcomes:
measure: Worst Leg Pain as Assessed by Visual Analog Scale (VAS)
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Gold River
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: Riverside
country: United States
state: California
city: Temecula
country: United States
state: California
city: Greenwood Village
country: United States
state: Colorado
city: Clermont
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami Gardens
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Newnan
country: United States
state: Georgia
city: Bloomington
country: United States
state: Illinois
city: Carmel
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Saint Peters
country: United States
state: Missouri
city: Hartsdale
country: United States
state: New York
city: Eugene
country: United States
state: Oregon
city: Charleston
country: United States
state: South Carolina
city: Plano
country: United States
state: Texas
city: Sandy
country: United States
state: Utah
city: Eichstätt
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Göppingen
country: Germany
state: Stuttgart
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Brasov
country: Romania
city: Bucuresti
country: Romania
city: Sibiu
country: Romania
city: Cadiz
country: Spain
state: Andalucía
city: Palma de Mallorca
country: Spain
state: Baleares
city: Badalona
country: Spain
state: Barcelona
city: Terrassa
country: Spain
state: Barcelona
city: Valladolid
country: Spain
state: Castilla Y León
city: Alcorcón
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Ourense
country: Spain
city: Valencia
country: Spain
Study officials:
References: