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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002725
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Iou hospital
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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