UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005575 |
|---|---|
| Receipt number | R000006535 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2011/05/10 |
| Last modified on | 2012/10/12 09:15:09 |
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Basic information
Public title
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
Acronym
Phase2 exploratory study of TRK-100STP
Scientific Title
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
Scientific Title:Acronym
Phase2 exploratory study of TRK-100STP
Region
| Japan |
Condition
Condition
Acquired degenerative lumbar spinal canal stenosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy, the safety and the dose response of TRK-100STP at a dose of 120 or 240 ug/day or placebo for patients with acquired lumbar spinal canal stenosis with neurogenic intermittent claudication.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1.Efficacy outcome measures
Objective assessments
Subjective assessments
QOL assessments
2.Safety outcome measures
Adverse events
Laboratory values
Vital signs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo
Interventions/Control_2
TRK-100STP 120ug/day
Interventions/Control_3
TRK-100STP 240ug/day
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients with spondylotic or degenerative spondylolosthetic LSCS, who does not have degenerative scoliotic and spondylolytic spondylolisthetic findings.
(2)Patients have cauda equine lesion type (cauda equine type or mixed type) symptoms.
Key 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.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Konno, Kazuhiro Chiba |
Organization
Fukushima Medical University, School of Medicine
School of Medicine, Keio University
Division name
Department of Orthopaedic Surgery, Department of Orthopaedic Surgery
Zip code
Address
1 Hikarigaoka, Fukushima City, Fukushima, 9-1, Shirogane 5-chome, Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
KAKEN PHARMACEUTICAL CO., LTD.
Division name
Clinical Development Department
Zip code
Address
28-8, Honkomagome 2-chome, Bunkyo-ku, Tokyo, 113-8650, Japan
TEL
03-5977-5111
Homepage URL
Sponsor or person
Institute
KAKEN PHARMACEUTICAL CO., LTD
Institute
Department
Personal name
Funding Source
Organization
KAKEN PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
TORAY INDUSTRIES, INC.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 09 | Day |
Last modified on
| 2012 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006535
