Neurologic Claudication in Patients With Lumbar Spinal Stenosis Clinical Trial
Official title:
A Randomized, Double-Blind, Comparative, Multi-Center, Phase Ⅳ Clinical Trial to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis
This trial is a comparative study of Opast tablet and Rikalin capsule 75mg and Rikalin capsule 75mg in combination with Opast tablet to evaluate improvement effectiveness of Opast tablet on subjective symptoms and neurologic claudication in patients with lumbar spinal stenosis.
Subjects who provided written consents voluntarily after receiving a sufficient explanation
about this trial will be assigned to one of groups(study group; limaprost, comparative group
1; pregabalin, comparative group 2; limaprost+ pregabalin) by randomization at the rate of
1:1:1.
Subjects will take assigned investigational drugs thrice a day for eight weeks by
double-blind and double-dummy methods, and they will visit the site two times at intervals
of four weeks.
At each site visit point, the improvement effectiveness will be comparatively evaluated by
evaluation of following endpoints;
Efficacy endpoints: ICD(initial claudication distance) at treadmill test (speed:3km/hr,
grade:0%), VAS in pain on lower extremities, EQ-5D and ODI Safety endpoints: Vital signs,
hematology/blood chemistry tests and adverse events, etc.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment