Migraine DisordersNCT01376141
Drug Use Investigation for IMIGRAN Tablet
An observational study of Migraine Disorders, run by GlaxoSmithKline.
Trial summary
The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Sumatriptan
- How many people
- 3,571 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Nov 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Male and female Japanese subjects with migraine disorders who were considered appropriate to prescribe sumatriptan tablet according to the prescribing information were eligible for this surveillance study.
Who may be able to join
- Subjects with migraine disorders
Who cannot join
- Subjects with hypersensitivity to sumatriptan
- Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
- Subjects with history of peripheral vascular disorder
- Subjects with history of cerebrovascular disorder or transient ischemic attacks
- Subjects with uncontrolled high-blood pressure
- Subjects with severe hepatic function disorder
- Subjects taking ergotamine, ergotamine derivative containing product, or 5-HT1B/1D agonist
- Subjects taking monoamine oxidaze inhibitor or use within 2 weeks of discontinuation
About this study
The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study.
A special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.
- Conditions
- Migraine Disorders
- Being tested
- Sumatriptan
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SumatriptanDrug
| Study group | Role | What they receive |
|---|---|---|
| Subjects prescribed IMIGRAN | Subjects with migraine disorders prescribed IMIGRAN during study period Receives: Drug: Sumatriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of incidence of adverse events in subjects with migraine disorders
Adverse event (AE), diagnosis or symptom, date of onset, outcome, date of outcome, seriousness, reason for judgement of "serious", intensity, relationship to IMIGRAN, other factors suspected to have relationship to AE
Measured: 2 months
Secondary outcomes (3)
Occurrence of arrhythmia
Occurrence of arrhythmia is investigated throughout study period.
Measured: 2 months
Occurrence of angina pectoris
Occurrence of angina pectoris is investigated throughout study period.
Measured: 2 months
Occurrence of myocardial infarction
Occurrence of myocardial infarction is investigated throughout study period.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startSep 2001
- Primary completionFeb 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,571 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376141
- Sponsor's protocol ID
- 112324
- Status last verified
- May 2017
- First submitted
- 3 Mar 2011
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for IMIGRAN Tablet
- ClinicalTrials.gov ID
- NCT01376141
- Acronym / sponsor ID
- 112324
- Conditions
- Migraine Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,571 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Primary completion
- Feb 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to detect adverse drug reactions (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy of sumatriptan tablet, and to discuss the need of special investigation and postmarketing clinical study.
A special focus was placed on the investigation of occurrence of "ischaemic heart disease-like events including arrhythmia, angina pectoris, and myocardial infarction" in the present study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects prescribed IMIGRAN | – | Drug: SumatriptanSubjects with migraine disorders prescribed IMIGRAN during study period |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female Japanese subjects with migraine disorders who were considered appropriate to prescribe sumatriptan tablet according to the prescribing information were eligible for this surveillance study.
Key inclusion criteria (1 listed)
- Subjects with migraine disorders
Key exclusion criteria (8 listed)
- Subjects with hypersensitivity to sumatriptan
- Subjects with history, symptoms, or signs of myocardial infarction, ischemic cardiac disease, or variant angina
- Subjects with history of peripheral vascular disorder
- Subjects with history of cerebrovascular disorder or transient ischemic attacks
- Subjects with uncontrolled high-blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sumatriptan | Drug | Subjects prescribed IMIGRAN |
Primary outcome
The number of incidence of adverse events in subjects with migraine disorders
Time frame: 2 months
Adverse event (AE), diagnosis or symptom, date of onset, outcome, date of outcome, seriousness, reason for judgement of "serious", intensity, relationship to IMIGRAN, other factors suspected to have relationship to AE
3 secondary outcomes
Occurrence of arrhythmia
Time frame: 2 months
Occurrence of angina pectoris
Time frame: 2 months
Occurrence of myocardial infarction
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of incidence of adverse events in subjects with migraine disorders (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.