NIPH Clinical Trials Search

UMIN ID: UMIN000001807

Registered date:30/03/2009

Efficacy and Safty of Long Acting Beraprost (TRK-100STP) for Lumbar Spinal Canal Stenosis with Intermittent Claudication :A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAcquired degenerative lumbar spinal canal stenosis
Date of first enrollment2009/04/01
Target sample size150
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Placebo TRK-100STP 120ug/day TRK-100STP 240ug/day


Primary Outcome1.Efficacy outcome measures Objective assessments Subjective assessments QOL assessments 2.Safety outcome measures Adverse events Laboratory values Vital signs
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum40years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria(1)Patients who have any complication, which could affect efficacy assessments. (2)Patients who is bleeding or have a tendency to bleed. (3)Patients are allergic to beraprost sodium. (4)Patients have severe disorders. (5)Patients who determined the principal investigator or the sub-investigator to be inadequate to participate in the trial.

Related Information


public contact
Address 28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, 113-8650, Japan Japan
Telephone 03-5977-5111
Affiliation KAKEN PHARMACEUTICAL CO., LTD. Clinical Development Department
scientific contact
Name Shinichi Konno, Kazuhiro Chiba
Address 1 Hikarigaoka, Fukushima City, Fukushima, 960-1295, Japan , 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan Japan
Affiliation Fukushima Medical University, School of Medicine School of Medicine, Keio University Department of Orthopaedic Surgery, Department of Orthopaedic Surgery