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

Lumbar Disc Disease Clinical Trial

Official title:

A Multicenter, Open-label Study of SI 6603 in Patients With Lumbar Disc Herniation (Phase III)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421601
• Other study ID #: 6603/1132
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: February 2018

Study information

• Verified date: March 2023
• Source: Seikagaku Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1011
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Intervertebral Disc Disease
• Intervertebral Disc Displacement
• Lumbar Disc Disease
• Spinal Diseases

Intervention

Drug:
• Condoliase
1.25 U, intradiscal injection, one time

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seikagaku Corporation

Countries where clinical trial is conducted

United States,  Germany,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAE)	A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that began or that worsened in severity after the investigational drug had been administered. All AEs, including intercurrent illnesses and regardless of the relationship to investigational drug, occurring during the study were documented from the signing of the informed consent form until completion of final visit. Concomitant illnesses, which existed before entry into the study, were not considered AEs unless they worsened during the treatment period. All AEs, regardless of the source of identification (e.g., physical examination, laboratory assessment, or reported by patient), had to be documented.	26 weeks
Secondary	Worst Leg Pain as Assessed by Visual Analog Scale (VAS)	Worst leg pain intensity during the past 24 hours assessed by Visual Analog Scale (VAS). Scores are recorded by making a handwritten mark on a 100 mm line that represents a continuum between "no pain" (0 mm) and "extreme pain" (100 mm).	26 weeks