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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

Tracking Information
First Submitted Date  ICMJE February 10, 2013
First Posted Date  ICMJE February 15, 2013
Last Update Posted Date February 15, 2013
Study Start Date  ICMJE July 2009
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2013)
pain [ Time Frame: at one hour after prescription ]
determining pain in Metoclopramide versus sumatriptan groups
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache
Official Title  ICMJE Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Migraine Disorders
Intervention  ICMJE
  • Drug: metoclopramide, injection,20mg, one time
    metoclopramide, intravenous injection,20mg, one time
    Other Name: plasil
  • Drug: Sumatriptan, injection, 6 mg, one time
    Sumatriptan, subcutaneous injection, 6 mg, one time
Study Arms  ICMJE
  • sumatriptan
    Patients who underwent 6 mg sumatriptan subcutaneous one time
    Intervention: Drug: Sumatriptan, injection, 6 mg, one time
  • Metoclopramide
    Patients who underwent 20 mg Metoclopramide intravenous one time
    Intervention: Drug: metoclopramide, injection,20mg, one time
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 13, 2013)
124
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01791400
Other Study ID Numbers  ICMJE ASD-1213-70
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hamidreza Shemshaki, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: babak masoumi, A.Professor Isfahan, Isfahan, Iran, Islamic Republic of
PRS Account Isfahan University of Medical Sciences
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP