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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shadi Asadollahi, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01814189
First received: March 14, 2013
Last updated: July 28, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Complete headache relief [ Time Frame: At 2 hours after first dose ] [ Designated as safety issue: No ]
    The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing.


Secondary Outcome Measures:
  • Complete headache relief [ Time Frame: At 0.5 hour, 1 hour, and 4 hours after first dose ] [ Designated as safety issue: No ]
    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. [ Time Frame: At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose. ] [ Designated as safety issue: No ]
    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. [ Time Frame: At 2-48 hours after first dose. ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 4-48 hours after second dose. ] [ Designated as safety issue: No ]
    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 [ Time Frame: At 2-48 hours after first dose. ] [ Designated as safety issue: No ]
    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. [ Time Frame: At 4 hours after first dose. ] [ Designated as safety issue: Yes ]
    Presence or absence of adverse events occurred 4 hours after first dosing.


Enrollment: 350
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814189

Locations
Iran, Islamic Republic of
Department of Neurology, Emam Hossein Hospital
Tehran, Iran, Islamic Republic of, 17666-33812
Sponsors and Collaborators
Shahid Beheshti Medical University
  More Information

No publications provided

Responsible Party: Shadi Asadollahi, Research Assistant of Neurology, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT01814189     History of Changes
Other Study ID Numbers: SB-045
Study First Received: March 14, 2013
Last Updated: July 28, 2013
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Migraine without Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Promethazine
Diphenhydramine
Sumatriptan
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on August 21, 2014