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

December 19, 2015 updated by: Yungjin Pharm. Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Health System, Severance Hospital
      • Seoul, Korea, Republic of, 139-707
        • Inje University Sanggye Paik Hospital
      • Seoul, Korea, Republic of, 130-872
        • KyungHee University Medical Center
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, Korea, Republic of, 431-070
        • Hallym University Sacred Heart Hospital
      • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
        • Hanyang University Guri Hospital
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Limaprost & Placebo
Limaprost 5㎍ tablet and a capsule of Pegabalin-Placebo thrice a day for 8 weeks.
Drug: Limaprost
Other Names:
  • 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 Names:
  • 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: Pregabalin
Other Names:
  • Rikalin capsule 75mg
Drug: Limaprost
Other Names:
  • Opast tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
baseline-adjusted Oswestry Disability Index score at 8 weeks after treatment
Time Frame: up to 8 weeks after first administration
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial Claudication Distance(ICD) on treadmill test
Time Frame: 4 and 8 weeks after first administration
  • 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
lower extremity pain score measured by Visual Analog Scale(VAS) 10cm
Time Frame: 4 and 8 weeks after first administration
  • 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
Mean ratio of change in score of EuroQuol 5D (EQ-5D)
Time Frame: 4 and 8 weeks after first administration
  • 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
Mean ratio of change in score of Oswestry Disability Index(ODI)
Time Frame: 4 and 8 weeks after first administration
  • 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 19, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YJ7-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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