Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
NCT ID: NCT01814189
Last Updated: 2013-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
350 participants
INTERVENTIONAL
2013-01-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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sumatriptan+promethazine (SPr)
The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).
Sumatriptan+Promethazine (SPr)
Sumatriptan+placebo (SP)
The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.
Sumatriptan+Promethazine (SPr)
Interventions
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Sumatriptan+Promethazine (SPr)
Eligibility Criteria
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Inclusion Criteria
* Subjects who have mean frequency of 2-8 migraine attacks per month.
Exclusion Criteria
* Uncontrolled hypertension (diastolic blood pressure \>95 mm Hg or systolic blood pressure \>160 mm Hg)
* History or clinical evidence of cerebrovascular or cardiovascular disorder
* Renal impairment or dialysis dependence
* Serious illness (physical or psychiatric disorders)
* Drugs and alcohol abuse
* Pregnancy and breastfeeding
* Allergy or hypersensitivity to promethazine or triptans
* Concurrent use of ergotamine-containing drugs, monoamine oxidize inhibitors, antidepressant, lithium
18 Years
65 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Shadi Asadollahi
Research Assistant of Neurology
Locations
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Department of Neurology, Emam Hossein Hospital
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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SB-045
Identifier Type: -
Identifier Source: org_study_id
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