Back to resultsEfficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
Primary Purpose
Migraine With Aura, Migraine Without Aura
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Sumatriptan+Promethazine (SPr)
Sponsored by
About this trial
This is an interventional treatment trial for Migraine With Aura
Eligibility 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
Sites / Locations
- Department of Neurology, Emam Hossein Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
sumatriptan+promethazine (SPr)
Sumatriptan+placebo (SP)
Arm Description
The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).
The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.
Outcomes
Primary Outcome Measures
Complete headache relief
The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.
Secondary Outcome Measures
Complete headache relief
The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing.
Headache improvement.
The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing.
Using the second dose of study medications.
The secondary endpoint variable was the use of second dose when the severity of headache was still moderate or severe after the first dose within 2-48 hours
Using rescue medication between 2 and 48 hours postdose
The secondary endpoint variable was the use of rescue medication (excluding triptans, and ergot-containing medication) within 4-48 hours after the second dose when headache severity was still at grade 2 ⁄ 3.
Rate of headache recurrence
The secondary endpoint variable was a return to moderate or severe pain within 48 hours of first dose subsequent to primary improvement to mild or no pain at 2 hours.
Occurrence of adverse events.
Presence or absence of adverse events occurred 4 hours after first dosing.
Full Information
NCT ID
NCT01814189
First Posted
March 14, 2013
Last Updated
July 28, 2013
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01814189
Brief Title
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
Official Title
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With Aura, Migraine Without Aura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sumatriptan+promethazine (SPr)
Arm Type
Active Comparator
Arm Description
The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).
Arm Title
Sumatriptan+placebo (SP)
Arm Type
Placebo Comparator
Arm Description
The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.
Intervention Type
Drug
Intervention Name(s)
Sumatriptan+Promethazine (SPr)
Primary Outcome Measure Information:
Title
Complete headache relief
Description
The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.
Time Frame
At 2 hours after first dose
Secondary Outcome Measure Information:
Title
Complete headache relief
Description
The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing.
Time Frame
At 0.5 hour, 1 hour, and 4 hours after first dose
Title
Headache improvement.
Description
The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing.
Time Frame
At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.
Title
Using the second dose of study medications.
Description
The secondary endpoint variable was the use of second dose when the severity of headache was still moderate or severe after the first dose within 2-48 hours
Time Frame
At 2-48 hours after first dose.
Title
Using rescue medication between 2 and 48 hours postdose
Description
The secondary endpoint variable was the use of rescue medication (excluding triptans, and ergot-containing medication) within 4-48 hours after the second dose when headache severity was still at grade 2 ⁄ 3.
Time Frame
At 4-48 hours after second dose.
Title
Rate of headache recurrence
Description
The secondary endpoint variable was a return to moderate or severe pain within 48 hours of first dose subsequent to primary improvement to mild or no pain at 2 hours.
Time Frame
At 2-48 hours after first dose.
Title
Occurrence of adverse events.
Description
Presence or absence of adverse events occurred 4 hours after first dosing.
Time Frame
At 4 hours after first dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Neurology, Emam Hossein Hospital
City
Tehran
ZIP/Postal Code
17666-33812
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment
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