Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
Information source: Shahid Beheshti Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine With Aura; Migraine Without Aura
Intervention: Sumatriptan+Promethazine (SPr) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Shahid Beheshti Medical University
Summary
The purpose of this study is to show the efficacy of promethazine in management of patients
with moderate to severe migraine
Clinical Details
Official title: Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Complete headache relief
Secondary outcome: Complete headache reliefHeadache improvement. Using the second dose of study medications. Using rescue medication between 2 and 48 hours postdose Rate of headache recurrence Occurrence of adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who aged 18 to 65 years with a clinical history of migraine with or without
aura (International Headache Society categories 1. 1 or 1. 2) for at least 1 year
- Subjects who have mean frequency of 2-8 migraine attacks per month.
Exclusion Criteria:
- Complex form of migraine, medication overuse headache, history of chronic
tension-type headache, ophthalmoplegic, basilar and hemiplegic migraine
- 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
Locations and Contacts
Department of Neurology, Emam Hossein Hospital, Tehran 17666-33812, Iran, Islamic Republic of
Additional Information
Starting date: January 2013
Last updated: July 28, 2013
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