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
Phase 2
- Conditions
- Acquired degenerative lumbar spinal canal stenosis
- Registration Number
- JPRN-UMIN000005575
- Lead Sponsor
- KAKEN PHARMACEUTICAL CO., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Patients who have any complication, which could affect efficacy assessments. (2)ABI is more than 0.9 (3)Patients who is bleeding or have a tendency to bleed. (4)Patients are allergic to beraprost sodium. (5)Patients have severe disorders. (6)Patients who determined the principal investigator or the sub-investigator to be inadequate to participate in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Efficacy outcome measures Objective assessments Subjective assessments QOL assessments 2.Safety outcome measures Adverse events Laboratory values Vital signs
- Secondary Outcome Measures
Name Time Method