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Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

NCT00557544 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-08-24

No results posted yet for this study

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

Conditions

Interventions

DRUG

metoclopramide

metoclopramide 0,15 mg/kg

DRUG

placebo

placebo per os

DRUG

ketoprofen

ketoprofen 1 mg/Kg

Sponsors & Collaborators

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Edoardo Guglia, MD · IRCCS Burlo Garofolo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-12-31
Completion
2010-06-30

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557544 on ClinicalTrials.gov