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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001807
Receipt No. R000002170
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 2009/03/30
Last modified on 2010/03/29

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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 and safety 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
80 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 radicular type or cauda equine lesion type (cauda equine type or mixed type) symptoms.

(3)ABI is more than 0.9.
Key exclusion 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.
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, 960-1295, Japan , 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
Email

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
Email

Sponsor
Institute KAKEN PHARMACEUTICAL CO., LTD.
Institute
Department

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
Email

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
2009 Year 03 Month 30 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
2009 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2010 Year 05 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
2009 Year 03 Month 27 Day
Last modified on
2010 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002170

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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