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Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

This study is not yet open for participant recruitment.
Study NCT00557544.   Last updated on November 13, 2007.   Information provided by IRCCS Burlo Garofolo

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Descriptive Information Fields
Brief Title  Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
Official Title  Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child
Brief Summary

This is a Randomized double blind trial with the aim to estimate the effectiveness of 3 therapeutic regimes per os on migraine pain:

  1. metoclopramide 0,15 mg/kg + placebo
  2. metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg
  3. ketoprofen 1 mg/Kg + placebo

Intensity of pain will be measured with linear 1-10 scale or analogic McGrath type scale every 20 min.

The main objective is the evaluation of healing times from pain in the 3 groups

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  evaluation of healing times from pain in the 3 groups [ Time Frame: 2 hours ]
Secondary Outcome Measure  evaluation of failures and necessity of rescue treatment after 2 hours and after 24 hours [ Time Frame: 24 hours ]
Condition  Child
Migraine
Intervention  Drug: metoclopramide and ketoprofen
Drug: metoclopramide and placebo
Drug: ketoprofen and placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  120
Start Date  January 2008
Completion Date January 2010
Eligibility Criteria 

Inclusion Criteria:

  • Children 6-17 years old with migraine presenting in emergency room

Exclusion Criteria:

  • Informed consensus not obtained
  • Occurring migraine still treated
  • Hemiplegic migraine
Gender Both
Ages 6 Years to 17 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Edoardo Guglia, MD     +390403785373     edigugl@gmail.com    
Contact: Federico Minen, MD     +390403785263     angela.decunto@libero.it    
Location Countries  Italy
Administrative Information Fields
NCT ID  NCT00557544
Organization ID rc 32/07
Secondary IDs ††
Study Sponsor  IRCCS Burlo Garofolo
Collaborators ††
Investigators 
Principal Investigator:     Edoardo Guglia, MD     IRCCS Burlo Garofolo    
Information Provided By IRCCS Burlo Garofolo
Verification Date November 2007
First Received Date  November 13, 2007
Last Updated Date November 13, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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