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.
| Status | Completed |
| Enrollment | 182 |
| Est. completion date | February 2014 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 75 Years |
| Eligibility |
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. - speed: 3km/hr, grade:0%, posture: should keep their lumbar spinal extended 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. - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do |
| Korea, Republic of | Hanyang University Guri Hospital | Guri-si | Gyeonggi-do |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Inje University Sanggye Paik Hospital | Seoul | |
| Korea, Republic of | KyungHee University Medical Center | Seoul | |
| Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul | |
| Korea, Republic of | Yonsei University Health System, Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yungjin Pharm. Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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) |
4 and 8 weeks after first administration | No |
| Secondary | 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) |
4 and 8 weeks after first administration | No |
| Secondary | 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) |
4 and 8 weeks after first administration | No |
| Secondary | 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) |
4 and 8 weeks after first administration | No |