UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002725 |
|---|---|
| Receipt number | R000003319 |
| Scientific Title | Efficacy of ramatroban in multiple sclerosis patients |
| Date of disclosure of the study information | 2009/11/22 |
| Last modified on | 2010/11/12 18:21:03 |
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Basic information
Public title
Efficacy of ramatroban in multiple sclerosis patients
Acronym
Efficacy of ramatroban
Scientific Title
Efficacy of ramatroban in multiple sclerosis patients
Scientific Title:Acronym
Efficacy of ramatroban
Region
| Japan |
Condition
Condition
Multiple sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy of ramatroban in MS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Suppression of the new lesion in the brain MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Addition of ramatroban to conventional MS therapy
Interventions/Control_2
Interventions/Control_3
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-responder to the conventional therapy in multiple sclerosis patients
Key exclusion criteria
pregnant woman
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Takahashi |
Organization
Iou hospital
Division name
Neurology
Zip code
Address
Ni73-1 Iwade-machi, Kanazawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Iou hospital
Division name
Neurology
Zip code
Address
TEL
076-258-1180
Homepage URL
Sponsor or person
Institute
Iou hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2009 | Year | 11 | Month | 22 | 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
All of the patients were treated with ramatroban (150 mg/day p.o.) added to conventinal MS therapy. The numbers of relapses were used as primary outcome measures. The patients were monitored for the adverse effects.
A patient with acute eruption by drug allergy discontinued ramatroban. Four of 5 patients could continue ramatroban treatment without any adverse effects. In 4 patients who could complete two years of therapy, there was significant difference in the mean annual relapse rates (before 4.0+/-2.8 SD; on ramatroban 0.8+/-0.5 SD ).
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
| 2008 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 07 | Day |
Last modified on
| 2010 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
