Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood - Tabular View

Tracking Information

First Received Date ^ICMJE

November 13, 2007

Last Updated Date

January 28, 2009

Start Date ^ICMJE

February 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

evaluation of healing times from pain in the 3 groups [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

evaluation of healing times from pain in the 3 groups [ Time Frame: 2 hours ]

Change History

Complete list of historical versions of study NCT00557544 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial [ Time Frame: 2 and 24 hours respectively ] [ Designated as safety issue: Yes ]
need of a rescue drug for lack of effect in every arms of the trial [ Time Frame: 2 hours and 24 hours for relapses ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

evaluation of failures and necessity of rescue treatment after 2 hours and after 24 hours [ Time Frame: 24 hours ]

Descriptive Information

Brief Title ^ICMJE

Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

Official Title ^ICMJE

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:

metoclopramide 0,15 mg/kg + placebo
metoclopramide 0,15 mg/Kg + ketoprofen 1 mg/kg
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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Migraine

Intervention ^ICMJE

Drug: metoclopramide
Drug: placebo
Drug: ketoprofen

Study Arms / Comparison Groups

Experimental: metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
Active Comparator: metoclopramide 0,15 mg/Kg + placebo per os
Active Comparator: ketoprofen 1 mg/Kg and placebo in single dose

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

June 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact: Edoardo Guglia, MD	+390403785373	edigugl@gmail.com
Contact: Federico Minen, MD	+390403785263	angela.decunto@libero.it

Location Countries ^ICMJE

Italy

Administrative Information

NCT ID ^ICMJE

NCT00557544

Responsible Party

IRCCS Burlo Garofolo, Edoardo Guglia

Study ID Numbers ^ICMJE

rc 32/07

Study Sponsor ^ICMJE

IRCCS Burlo Garofolo

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Edoardo Guglia, MD

IRCCS Burlo Garofolo

Information Provided By

IRCCS Burlo Garofolo

Verification Date

January 2009

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