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

NCT01888536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2015-12-22

No results posted yet for this study

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.

Conditions

  • Neurologic Claudication in Patients With Lumbar Spinal Stenosis

Interventions

DRUG

Limaprost

DRUG

Pregabalin

DRUG

Placebo(for Pregabalin)

mimic Pregabalin 75mg capsule

DRUG

Placebo(for Limaprost)

mimic Limaprost tablet

Sponsors & Collaborators

  • Yungjin Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Seong-Hwan Moon, M.D.,Ph.D. · Yonsei University College of Medicine Severance Hospital

  • Jin Hyok Kim, M.D.,Ph.D. · Inje University

  • Jae Hyup Lee, M.D.,Ph.D. · SMG-SNU Boramae Medical Center

  • Suk Kyung Soo, M.D.,Ph.D. · Kyunghee University Medical Center

  • Ho Joong Kim, M.D.,Ph.D. · Seoul National University Bundang Hospital

  • Ye Soo Park, M.D.,Ph.D. · Hanyang University

  • Moon Soo Park, M.D.,Ph.D. · Hallym University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-10-31
Completion
2014-02-28

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01888536 on ClinicalTrials.gov