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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01791400
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences

Study Description
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Brief Summary:
The purpose of this study is to determine which drug makes lower migraine headache

Condition or disease Intervention/treatment Phase
Migraine Disorders Drug: metoclopramide, injection,20mg, one time Drug: Sumatriptan, injection, 6 mg, one time Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache
Study Start Date : July 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
sumatriptan
Patients who underwent 6 mg sumatriptan subcutaneous one time
 Drug: Sumatriptan, injection, 6 mg, one time
Sumatriptan, subcutaneous injection, 6 mg, one time
Metoclopramide
Patients who underwent 20 mg Metoclopramide intravenous one time
 Drug: metoclopramide, injection,20mg, one time
metoclopramide, intravenous injection,20mg, one time
Other Name: plasil


Outcome Measures
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Primary Outcome Measures :
  1. pain [ Time Frame: at one hour after prescription ]
    determining pain in Metoclopramide versus sumatriptan groups


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791400


Locations
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Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Principal Investigator: babak masoumi, A.Professor Isfahan, Isfahan, Iran, Islamic Republic of
More Information
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Additional Information:
Isfahan university of medical sciences  This link exits the ClinicalTrials.gov site

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Responsible Party: Hamidreza Shemshaki, Research Assistant, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01791400    
Other Study ID Numbers: ASD-1213-70
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Hamidreza Shemshaki, Isfahan University of Medical Sciences:
Metoclopramide
Sumatriptan
migraine
headache
Additional relevant MeSH terms:
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Sumatriptan
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Metoclopramide
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents