Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

Sponsor

IRCCS Burlo Garofolo (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00557544

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: metoclopramide Drug: placebo Drug: ketoprofen	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose	Drug: metoclopramide metoclopramide 0,15 mg/kg Drug: ketoprofen ketoprofen 1 mg/Kg
Active Comparator: 2 metoclopramide 0,15 mg/Kg + placebo per os	Drug: metoclopramide metoclopramide 0,15 mg/kg Drug: placebo placebo per os
Active Comparator: 3 ketoprofen 1 mg/Kg and placebo in single dose	Drug: placebo placebo per os Drug: ketoprofen ketoprofen 1 mg/Kg

Arm

Intervention/Treatment

Experimental: 1

metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose

Drug: metoclopramide

metoclopramide 0,15 mg/kg

Drug: ketoprofen

ketoprofen 1 mg/Kg

Active Comparator: 2

metoclopramide 0,15 mg/Kg + placebo per os

Drug: metoclopramide

metoclopramide 0,15 mg/kg

Drug: placebo

placebo per os

Active Comparator: 3

ketoprofen 1 mg/Kg and placebo in single dose

Drug: placebo

placebo per os

Drug: ketoprofen

ketoprofen 1 mg/Kg

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial [2 and 24 hours respectively]
need of a rescue drug for lack of effect in every arms of the trial [2 hours and 24 hours for relapses]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edoardo Guglia	Trieste		Italy	34100

Sponsors and Collaborators

IRCCS Burlo Garofolo

Investigators

Principal Investigator: Edoardo Guglia, MD, IRCCS Burlo Garofolo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

IRCCS Burlo Garofolo

ClinicalTrials.gov Identifier:

NCT00557544

Other Study ID Numbers:

rc 32/07

First Posted:

Nov 14, 2007

Last Update Posted:

Aug 24, 2017

Last Verified:

Aug 1, 2017

Keywords provided by IRCCS Burlo Garofolo

Additional relevant MeSH terms:

Migraine Disorders

Ketoprofen

Metoclopramide

Study Results

No Results Posted as of Aug 24, 2017