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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Limaprost & Placebo | Experimental | Limaprost 5㎍ tablet and a capsule of Pegabalin-Placebo thrice a day for 8 weeks. |
|
| Pregabalin & Placebo | Active Comparator | Pregabalin 75mg capsule and a tablet of Limaprost-Placebo thrice a day for 8 weeks. |
|
| Limaprost+Pregabalin | Active Comparator | Limaprost 5㎍ tablet and Pregabalin 75mg capsule thrice a day for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limaprost | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 8 weeks after first administration |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Claudication Distance(ICD) on treadmill test |
| 4 and 8 weeks after first administration |
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Inclusion Criteria:
Subject is fully understand the clinical trial and obtained informed consent.
Age 20-75years.
Patients with a confirmed diagnosis of waist of spinal canal stenosis.
Limb pain caused by waist of spinal canal stenosis index of VAS 3 or more patients.
Subject who has numbness symptom on lower extremity(ies) and intermittent claudication that are due to spinal canal stenosis and fulfills both of following criteria at the same time
When screening visit, a medical examination by interview had the following symptoms in subjects ; In daily life walking, when walked by within 20 minutes on flatland, the subject can feel the symptoms (numbness, pain or tightness on lower extremity(ies), etc.)
Subject who experienced numbness, pain, tightness or other similar symptom(s) on lower extremity within 15 minutes from test start at baseline(D1) evaluation.
Exclusion Criteria:
Pregnant or lactating women of childbearing potential not employing adequate contraception.
Patients who have the hereditary problem of galactose intolerance, Lapp lactase deficiency or grape sugar-galactose absorption defect.
Patients with systemic disease affecting the lower limbs.
Patients who have cauda equina syndrome.
Patients with acute osteoporosis compression fracture in lumbar vertebra.
Patients who have gait disturbance of degenerative arthritis by hip joint, knee joint, ankle joint.
At least one month before the start of the study, patients use of steroid drug except lumbar dura mater.
6 month before the start of the study, patients with ischaemic disease in blood vessel, lung or the coronary artery, varicose artery.
Patients with lumbar necrosis in head of femur avascular necrosis, necrotic foot ulcer.
Patients surgery by lumbar fusion and lumbar decompression.
Patients with renal disease or need to hemodialysis.
3 month before the start of the study, patients participated in another clinical research.
Patients with difficult understanding spirit incompetence, lack of will or language barrier.
The investigator judged seriously ill patients need surgery patient.
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| Name | Affiliation | Role |
|---|---|---|
| Seong-Hwan Moon, M.D.,Ph.D. | Yonsei University College of Medicine Severance Hospital | Principal Investigator |
| Jin Hyok Kim, M.D.,Ph.D. | Inje University | Principal Investigator |
| Jae Hyup Lee, M.D.,Ph.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Suk Kyung Soo, M.D.,Ph.D. | Kyunghee University Medical Center | Principal Investigator |
| Ho Joong Kim, M.D.,Ph.D. | Seoul National University Bundang Hospital | Principal Investigator |
| Ye Soo Park, M.D.,Ph.D. | Hanyang University Guri Hospital | Principal Investigator |
| Moon Soo Park, M.D.,Ph.D. | Hallym University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | 431-070 | South Korea | ||
| Hanyang University Guri Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27045252 | Derived | Kim HJ, Kim JH, Park YS, Suk KS, Lee JH, Park MS, Moon SH. Comparative study of the efficacy of limaprost and pregabalin as single agents and in combination for the treatment of lumbar spinal stenosis: a prospective, double-blind, randomized controlled non-inferiority trial. Spine J. 2016 Jun;16(6):756-63. doi: 10.1016/j.spinee.2016.02.049. Epub 2016 Mar 29. |
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| Pregabalin |
| Drug |
|
|
| Placebo(for Pregabalin) | Drug | mimic Pregabalin 75mg capsule |
|
| Placebo(for Limaprost) | Drug | mimic Limaprost tablet |
|
| lower extremity pain score measured by Visual Analog Scale(VAS) 10cm |
| 4 and 8 weeks after first administration |
| Mean ratio of change in score of EuroQuol 5D (EQ-5D) |
| 4 and 8 weeks after first administration |
| Mean ratio of change in score of Oswestry Disability Index(ODI) |
| 4 and 8 weeks after first administration |
| Guri-si |
| Gyeonggi-do |
| 471-701 |
| South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea |
| Yonsei University Health System, Severance Hospital | Seoul | Seoul | 120-752 | South Korea |
| KyungHee University Medical Center | Seoul | Seoul | 130-872 | South Korea |
| Inje University Sanggye Paik Hospital | Seoul | Seoul | 139-707 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | Seoul | 156-707 | South Korea |
| ID | Term |
|---|---|
| C059238 | limaprost |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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