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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
182
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Yonsei University Health System, Severance Hospital
Seoul, Seoul, South Korea
baseline-adjusted Oswestry Disability Index score at 8 weeks after treatment
baseline-adjusted Oswestry Disability Index score at 8 weeks after treatment between study group(limaprost) and comparative group1(pregabalin) and combination group (limaprost + pregabalin)
Time frame: up to 8 weeks after first administration
Initial Claudication Distance(ICD) on treadmill test
* Improvement of ICD at 4 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin) * Improvement of ICD at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group 2(limaprost+ pregabalin)
Time frame: 4 and 8 weeks after first administration
lower extremity pain score measured by Visual Analog Scale(VAS) 10cm
* Change in VAS at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin) * Change in VAS at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group 2(limaprost+ pregabalin)
Time frame: 4 and 8 weeks after first administration
Mean ratio of change in score of EuroQuol 5D (EQ-5D)
* Change in EQ-5D at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin) * Change in EQ-5D at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group 2(limaprost+ pregabalin)
Time frame: 4 and 8 weeks after first administration
Mean ratio of change in score of Oswestry Disability Index(ODI)
* Change in ODI at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin) * Change in ODI at 4, 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group 2(limaprost+ pregabalin)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
mimic Limaprost tablet
KyungHee University Medical Center
Seoul, Seoul, South Korea
Inje University Sanggye Paik Hospital
Seoul, Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea
Time frame: 4 and 8 weeks after first administration