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Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
metoclopramide, injection,20mg, one time
Sumatriptan, injection, 6 mg, one time
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring Metoclopramide, Sumatriptan, migraine, headache

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 20-60 years old and presented with acute headache similar to previous episodes,
  • with or without phonophobia,
  • photophobia,
  • vomiting or nausea.

Exclusion Criteria:

  • fever or neck stiffness,
  • altered mental state,
  • pregnancy,
  • recent trauma or seizure (within 24 hours),
  • focal neurological abnormality on physical examination,
  • allergy to metoclopramide,
  • hypertension,
  • cardiovascular diseases.

Also if the patients had taken a triptan or ergot during the last 24 hours were excluded from the study.

Sites / Locations

  • Al-zahra university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

sumatriptan

Metoclopramide

Arm Description

Patients who underwent 6 mg sumatriptan subcutaneous one time

Patients who underwent 20 mg Metoclopramide intravenous one time

Outcomes

Primary Outcome Measures

pain
determining pain in Metoclopramide versus sumatriptan groups

Secondary Outcome Measures

Full Information

First Posted
February 10, 2013
Last Updated
February 13, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01791400
Brief Title
Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache
Official Title
Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine which drug makes lower migraine headache
Detailed Description
There are different options to manage benign headache in emergency department.The investigators compared Intravenous metoclopramide with Subcutaneous sumatriptan to relieve pain in emergency department.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
Metoclopramide, Sumatriptan, migraine, headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sumatriptan
Arm Type
Other
Arm Description
Patients who underwent 6 mg sumatriptan subcutaneous one time
Arm Title
Metoclopramide
Arm Type
Other
Arm Description
Patients who underwent 20 mg Metoclopramide intravenous one time
Intervention Type
Drug
Intervention Name(s)
metoclopramide, injection,20mg, one time
Other Intervention Name(s)
plasil
Intervention Description
metoclopramide, intravenous injection,20mg, one time
Intervention Type
Drug
Intervention Name(s)
Sumatriptan, injection, 6 mg, one time
Intervention Description
Sumatriptan, subcutaneous injection, 6 mg, one time
Primary Outcome Measure Information:
Title
pain
Description
determining pain in Metoclopramide versus sumatriptan groups
Time Frame
at one hour after prescription

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20-60 years old and presented with acute headache similar to previous episodes, with or without phonophobia, photophobia, vomiting or nausea. Exclusion Criteria: fever or neck stiffness, altered mental state, pregnancy, recent trauma or seizure (within 24 hours), focal neurological abnormality on physical examination, allergy to metoclopramide, hypertension, cardiovascular diseases. Also if the patients had taken a triptan or ergot during the last 24 hours were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
babak masoumi, A.Professor
Organizational Affiliation
Isfahan, Isfahan, Iran, Islamic Republic of
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-zahra university hospital
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Links:
URL
http://www.mui.ac.ir
Description
Isfahan university of medical sciences

Learn more about this trial

Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache

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