Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01814189

Collaborator

(none)

350

Enrollment

Location

Arms

Duration (Months)

118.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Migraine With Aura Migraine Without Aura	Drug: Sumatriptan+Promethazine (SPr)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment: a Randomized, Double Blind Clinical Trial

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sumatriptan+promethazine (SPr) The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).	Drug: Sumatriptan+Promethazine (SPr)
Placebo Comparator: Sumatriptan+placebo (SP) The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.	Drug: Sumatriptan+Promethazine (SPr)

Arm

Intervention/Treatment

Active Comparator: sumatriptan+promethazine (SPr)

The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg).

Drug: Sumatriptan+Promethazine (SPr)

Placebo Comparator: Sumatriptan+placebo (SP)

The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine.

Drug: Sumatriptan+Promethazine (SPr)

Outcome Measures

Primary Outcome Measures

Complete headache relief [At 2 hours after first dose]
The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.

Secondary Outcome Measures

Complete headache relief [At 0.5 hour, 1 hour, and 4 hours after first dose]
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. [At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose.]
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. [At 2-48 hours after first dose.]
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 [At 4-48 hours after second dose.]
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 [At 2-48 hours after first dose.]
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. [At 4 hours after first dose.]
Presence or absence of adverse events occurred 4 hours after first dosing.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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