Clinical trial NCT01941563: A Study of SI-6603 in Patients With Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intervertebral Disc Disease
Lumbar Disc Disease
Lead sponsor: Seikagaku Corporation
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 385
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Leg pain
timeFrame: 13 weeks
Secondary outcomes:
measure: Responder rate evaluation
timeFrame: 13 weeks
Other outcomes:
Locations:
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: Murrieta
country: United States
state: California
city: Riverside
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Merritt Island
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Orlando
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: Sunrise
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: State College
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Sandy
country: United States
state: Utah
city: Edmonds
country: United States
state: Washington
Study officials:
References: