NCT01888536

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Yungjin Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurologic Claudication in Patients With Lumbar Spinal Stenosis

Interventions

Type	Name	Description
DRUG	Limaprost
DRUG	Pregabalin
DRUG	Placebo(for Pregabalin)	mimic Pregabalin 75mg capsule
DRUG	Placebo(for Limaprost)	mimic Limaprost tablet

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-10-01
• Completion: 2014-02-01
• First posted: 2013-06-27
• Last updated: 2015-12-22

Locations

7 sites across 1 country: South Korea