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) studied | Acquired degenerative lumbar spinal canal stenosis |
| Date of first enrollment | 2009/04/01 |
| Target sample size | 150 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Placebo TRK-100STP 120ug/day TRK-100STP 240ug/day |
Outcome(s)
| Primary Outcome | 1.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 minimum | 40years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male 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
| Primary Sponsor | KAKEN PHARMACEUTICAL CO., LTD. |
|---|---|
| Secondary Sponsor | TORAY INDUSTRIES, INC. |
| Source(s) of Monetary Support | KAKEN PHARMACEUTICAL CO., LTD. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| 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 |
| Telephone | |
| Affiliation | Fukushima Medical University, School of Medicine School of Medicine, Keio University Department of Orthopaedic Surgery, Department of Orthopaedic Surgery |