SI-6603 Versus Placebo in Patients With Lumbar Disc Herniation
A Multicenter, Randomized, Double-blind Recommended Dose-finding Study of SI-6603 in Patients With Lumbar Disc Herniation (Phase II/III Study)
1 other identifier
interventional
195
1 country
8
Brief Summary
The purpose of this study is to determine whether SI-6603 is effective in the treatment of lumbar disc herniation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2008
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedMarch 23, 2023
March 1, 2023
1.8 years
February 27, 2008
March 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in leg pain from baseline.
13 weeks
Secondary Outcomes (1)
The leg pain
At each assessment time point
Study Arms (4)
I
EXPERIMENTALII
EXPERIMENTALIII
EXPERIMENTALIV
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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 lower leg
- Patients with no improvement from pharmacotherapy or concomitant treatment with drug and nerve block
You may not qualify if:
- Patients who have 2 or more lumbar disc herniations as assessed by MRI
- Patients with "extrusion-type" or "sequestration-type" herniation in whom a rupture into the posterior longitudinal ligament is identified by MRI
- Patients who have received nerve block within 3 weeks before screening
- Patients who have undergone lumbar operation, chemonucleolysis, or percutaneous nucleotomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Chugoku Area
Chugoku, Japan
Chubu Area
Chūbu, Japan
Hokkaido Area
Hokkaido, Japan
Kansai Area
Kansai, Japan
Kanto Area
Kanto, Japan
Kyushu Area
Kyushu, Japan
Shikoku Area
Shikoku, Japan
Tohoku Area
Tōhoku, Japan
Related Publications (1)
Matsuyama Y, Chiba K, Iwata H, Seo T, Toyama Y. A multicenter, randomized, double-blind, dose-finding study of condoliase in patients with lumbar disc herniation. J Neurosurg Spine. 2018 May;28(5):499-511. doi: 10.3171/2017.7.SPINE161327. Epub 2018 Feb 9.
PMID: 29424676DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 13, 2008
Study Start
January 1, 2008
Primary Completion
November 1, 2009
Study Completion
August 1, 2010
Last Updated
March 23, 2023
Record last verified: 2023-03