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NCT00557544 Clinical Trial

Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

Migraine Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00557544
Other study ID # rc 32/07
Secondary ID
Status Withdrawn
Phase Phase 3
First received November 13, 2007
Last updated August 23, 2017
Start date June 2009
Est. completion date June 2010

Study information
Verified date August 2017
Source IRCCS Burlo Garofolo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• metoclopramide
metoclopramide 0,15 mg/kg
• placebo
placebo per os
• ketoprofen
ketoprofen 1 mg/Kg

Locations
Country Name City State
Italy Edoardo Guglia Trieste

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary evaluation of healing times from pain in the 3 groups 2 hours
Secondary comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial 2 and 24 hours respectively
Secondary need of a rescue drug for lack of effect in every arms of the trial 2 hours and 24 hours for relapses
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