Status:
COMPLETED
A Study to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis
Lead Sponsor:
Yungjin Pharm. Co., Ltd.
Conditions:
Neurologic Claudication in Patients With Lumbar Spinal Stenosis
Eligibility:
All Genders
20-75 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT01888536
Start Date
February 1 2013
End Date
February 1 2014
Last Update
December 22 2015
Active Locations (7)
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1
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea, 431-070
2
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, South Korea, 471-701
3
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
4
Yonsei University Health System, Severance Hospital
Seoul, Seoul, South Korea, 120-752