UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003490 |
|---|---|
| Receipt number | R000004227 |
| Scientific Title | Comparison of preference for triptans in migraine patients: a randomized,open-label,crossover prospective study |
| Date of disclosure of the study information | 2010/04/15 |
| Last modified on | 2012/04/14 10:31:29 |
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Basic information
Public title
Comparison of preference for triptans in migraine patients: a randomized,open-label,crossover prospective study
Acronym
Comparison of preference for triptans in migraine patients: a randomized,open-label,crossover prospective study
Scientific Title
Comparison of preference for triptans in migraine patients: a randomized,open-label,crossover prospective study
Scientific Title:Acronym
Comparison of preference for triptans in migraine patients: a randomized,open-label,crossover prospective study
Region
| Japan |
Condition
Condition
migraine
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess relationship between patient preference for triptans and patient characteristics
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
#intensity of headache at 1 hour after taking the medication
#intensity of headache at 2 hours after taking the medication
#presence or absence of recurrence of migraine from 2 through 24 hours after taking the medication
Key secondary outcomes
#frequency of attacks
#consumption of triptans per 8 weeks
#consumption of nonsteroidal antiinflammatory drugs(NSAIDs) and other analgestics
#HIT-6 scores
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.Sumatriptan succinate 50mg
2.Eletriptan hydrobronide 20mg
3.Naratriptan hydrochloride 2.5mg
4.Zolmitriptan 2.5mg
5.Rizatriptan benzoate 10mg
Duration of treatment periods:8 weeks per a treatment,total 40weeks
Interventions/Control_2
1.Eletriptan hydrobronide 20mg
2.Sumatriptan succinate 50mg
3.Naratriptan hydrochloride 2.5mg
4.Rizatriptan benzoate 10mg
5.Zolmitriptan 2.5mg
Duration of treatment periods:8weeks per a treatment,total 40weeks
Interventions/Control_3
1.Naratriptan hydrochloride 2.5mg
2.Eletriptan hydrobronide 20mg
3.Sumatriptan succinate 50mg
4.Zolmitriptan 2.5mg
5.Rizatriptan benzoate 10mg
Duration of treatment periods:8weeks per a treatment,total 40weeks
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients who are diagnosed with migraine according to the International Classification of Headache Disorders 2nd Edition(ICHD-II)
2)Patients who occur attacks of migraine 2 times or more per month
3)Triptan-naive patients or patients who don't determined a preference for triptans
4)Onset of migraine before the age of 50 years
5)Patients between 18 and 65 years of age
6)Both male and female patient
7)Patients who are provided informed,written consent for participation
Key exclusion criteria
1)Patients with headache which is inability to distinguish between migraine and nonmigraine
2)Female who are pregnant or may be pregnant
3)Lactation
4)Patients with renal or hepatic impairment
5)Patients with history of myocardial infarction or with symptoms of ischemic heart disease
6)Patients with peripheral vascular disease
7)Patients with history of epileptiform attack or with brain disorder
8)Patients on monoamine oxidase inhibitors or within 2 weeks of discontinuation of monoamine oxidase inhibitors
9)Patients on HIV protease inhibitors
10)Hemodialysis patients
11)Patients on propranolol
12)Uncontrolled hypertension patients
13)Patients with psychiatric disorder which affect participation
14)Patients with hypersensitivity to any component of the study medications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Atsuda |
Organization
School of pharmacy,Kitasato university
Division name
Pharmacy practice and science Department of clinical pharmacy Center for clinical pharmacy and clinical sciences
Zip code
Address
5-9-1,SHIROKANE,MINATO-KU,TOKYO,108-8641,JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Usui |
Organization
School of pharmacy,Kitasato university
Division name
Pharmacy practice and science Department of clinical pharmacy Center for clinical pharmacy and clini
Zip code
Address
5-9-1,SHIROKANE,MINATO-KU,TOKYO,108-8641,JAPAN
TEL
Homepage URL
Sponsor or person
Institute
School of pharmacy, Kitasato university
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
Kitasato Institute Hospital headache center
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
北里大学北里研究所病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 14 | Day |
Last modified on
| 2012 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004227
