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

Primary Purpose

Neurologic Claudication in Patients With Lumbar Spinal Stenosis

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Limaprost

Pregabalin

Placebo(for Pregabalin)

Placebo(for Limaprost)

About this trial

This is an interventional treatment trial for Neurologic Claudication in Patients With Lumbar Spinal Stenosis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hallym University Sacred Heart Hospital
Hanyang University Guri Hospital
Seoul National University Bundang Hospital
Yonsei University Health System, Severance Hospital
KyungHee University Medical Center
Inje University Sanggye Paik Hospital
SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Limaprost & Placebo

Pregabalin & Placebo

Limaprost+Pregabalin

Arm Description

Limaprost 5㎍ tablet and a capsule of Pegabalin-Placebo thrice a day for 8 weeks.

Pregabalin 75mg capsule and a tablet of Limaprost-Placebo thrice a day for 8 weeks.

Limaprost 5㎍ tablet and Pregabalin 75mg capsule thrice a day for 8 weeks.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

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)

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)

Full Information

NCT ID

NCT01888536

First Posted

June 25, 2013

Last Updated

December 19, 2015

Sponsor

Yungjin Pharm. Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01888536

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yungjin Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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 symptoms and neurologic claudication in patients with lumbar spinal stenosis.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurologic Claudication in Patients With Lumbar Spinal Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

182 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Limaprost & Placebo

Arm Type

Experimental

Arm Description

Limaprost 5㎍ tablet and a capsule of Pegabalin-Placebo thrice a day for 8 weeks.

Arm Title

Pregabalin & Placebo

Arm Type

Active Comparator

Arm Description

Pregabalin 75mg capsule and a tablet of Limaprost-Placebo thrice a day for 8 weeks.

Arm Title

Limaprost+Pregabalin

Arm Type

Active Comparator

Arm Description

Limaprost 5㎍ tablet and Pregabalin 75mg capsule thrice a day for 8 weeks.

Intervention Type

Drug

Intervention Name(s)

Limaprost

Other Intervention Name(s)

Opast tablet

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Other Intervention Name(s)

Rikalin capsule 75mg

Intervention Type

Drug

Intervention Name(s)

Placebo(for Pregabalin)

Intervention Description

mimic Pregabalin 75mg capsule

Intervention Type

Drug

Intervention Name(s)

Placebo(for Limaprost)

Intervention Description

mimic Limaprost tablet

Primary Outcome Measure Information:

Title

baseline-adjusted Oswestry Disability Index score at 8 weeks after treatment

Description

baseline-adjusted Oswestry Disability Index score at 8 weeks after treatment between study group(limaprost) and comparative group1(pregabalin) and combination group (limaprost + pregabalin)

Time Frame

up to 8 weeks after first administration

Secondary Outcome Measure Information:

Title

Initial Claudication Distance(ICD) on treadmill test

Description

Time Frame

4 and 8 weeks after first administration

Title

lower extremity pain score measured by Visual Analog Scale(VAS) 10cm

Description

Time Frame

4 and 8 weeks after first administration

Title

Mean ratio of change in score of EuroQuol 5D (EQ-5D)

Description

Time Frame

4 and 8 weeks after first administration

Title

Mean ratio of change in score of Oswestry Disability Index(ODI)

Description

Time Frame

4 and 8 weeks after first administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: