A Study to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis
NCT ID: NCT01888536
Last Updated: 2015-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
182 participants
INTERVENTIONAL
2013-02-28
2014-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Limaprost & Placebo
Limaprost 5㎍ tablet and a capsule of Pegabalin-Placebo thrice a day for 8 weeks.
Limaprost
Placebo(for Pregabalin)
mimic Pregabalin 75mg capsule
Pregabalin & Placebo
Pregabalin 75mg capsule and a tablet of Limaprost-Placebo thrice a day for 8 weeks.
Pregabalin
Placebo(for Limaprost)
mimic Limaprost tablet
Limaprost+Pregabalin
Limaprost 5㎍ tablet and Pregabalin 75mg capsule thrice a day for 8 weeks.
Limaprost
Pregabalin
Interventions
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Limaprost
Pregabalin
Placebo(for Pregabalin)
mimic Pregabalin 75mg capsule
Placebo(for Limaprost)
mimic Limaprost tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* speed: 3km/hr, grade:0%, posture: should keep their lumbar spinal extended
Exclusion Criteria
* 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.
* serum creatinine \> 2xUNL
* 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.
20 Years
75 Years
ALL
No
Sponsors
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Yungjin Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Seong-Hwan Moon, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yonsei University College of Medicine Severance Hospital
Jin Hyok Kim, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Inje University
Jae Hyup Lee, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Suk Kyung Soo, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kyunghee University Medical Center
Ho Joong Kim, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Ye Soo Park, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Moon Soo Park, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hallym University Medical Center
Locations
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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
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
Countries
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References
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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.
Other Identifiers
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YJ7-401
Identifier Type: -
Identifier Source: org_study_id