A Study to Evaluate Efficacy of 『Opast Tablet』for Neurologic Claudication in Patients With Lumbar Spinal Stenosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yungjin Pharm. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01888536
First received: June 25, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Neurologic Claudication in Patients With Lumbar Spinal Stenosis
Drug: Limaprost
Drug: Pregabalin
Drug: Placebo(for Pregabalin)
Drug: Placebo(for Limaprost)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Yungjin Pharm. Co., Ltd.:

Primary Outcome Measures:
  • Initial Claudication Distance(ICD) on treadmill test [ Time Frame: up to 8 weeks after first administration ] [ Designated as safety issue: No ]
    : Improvement of ICD at 8 weeks after first administration compared to baseline, between study group(limaprost) and comparative group1(pregabalin)


Secondary Outcome Measures:
  • Initial Claudication Distance(ICD) on treadmill test [ Time Frame: 4 and 8 weeks after first administration ] [ Designated as safety issue: No ]
    • 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)

  • lower extremity pain score measured by Visual Analog Scale(VAS) 10cm [ Time Frame: 4 and 8 weeks after first administration ] [ Designated as safety issue: No ]
    • 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)

  • Mean ratio of change in score of EuroQuol 5D (EQ-5D) [ Time Frame: 4 and 8 weeks after first administration ] [ Designated as safety issue: No ]
    • 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)

  • Mean ratio of change in score of Oswestry Disability Index(ODI) [ Time Frame: 4 and 8 weeks after first administration ] [ Designated as safety issue: No ]
    • 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)


Enrollment: 182
Study Start Date: February 2013
Study Completion Date: February 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Limaprost & Placebo
Limaprost 5㎍ tablet and a capsule of Pegabalin-Placebo thrice a day for 8 weeks.
Drug: Limaprost
Other Name: Opast tablet
Drug: Placebo(for Pregabalin)
mimic Pregabalin 75mg capsule
Active Comparator: Pregabalin & Placebo
Pregabalin 75mg capsule and a tablet of Limaprost-Placebo thrice a day for 8 weeks.
Drug: Pregabalin
Other Name: Rikalin capsule 75mg
Drug: Placebo(for Limaprost)
mimic Limaprost tablet
Active Comparator: Limaprost+Pregabalin
Limaprost 5㎍ tablet and Pregabalin 75mg capsule thrice a day for 8 weeks.
Drug: Limaprost
Other Name: Opast tablet
Drug: Pregabalin
Other Name: Rikalin capsule 75mg

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, 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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01888536

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, Korea, Republic of, 431-070
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of, 139-707
KyungHee University Medical Center
Seoul, Korea, Republic of, 130-872
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Yonsei University Health System, Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yungjin Pharm. Co., Ltd.
Investigators
Principal Investigator: 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
Principal Investigator: Moon Soo Park, M.D.,Ph.D. Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Yungjin Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT01888536     History of Changes
Other Study ID Numbers: YJ7-401
Study First Received: June 25, 2013
Last Updated: September 24, 2014
Health Authority: Korea: Institutional Review Board
Korea: Ministry of Food and Drug Safety

Additional relevant MeSH terms:
Constriction, Pathologic
Intermittent Claudication
Spinal Stenosis
Arterial Occlusive Diseases
Arteriosclerosis
Bone Diseases
Cardiovascular Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Signs and Symptoms
Spinal Diseases
Vascular Diseases
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014