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

Sponsor:	IRCCS Burlo Garofolo
Information provided by:	IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:	NCT00557544

Purpose

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	Intervention	Phase
Migraine	Drug: metoclopramide Drug: placebo Drug: ketoprofen	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine

Drug Information available for: Ketoprofen Metoclopramide hydrochloride Metoclopramide

U.S. FDA Resources

Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	120
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator metoclopramide 0,15 mg/Kg + placebo per os	Drug: metoclopramide metoclopramide 0,15 mg/kg Drug: placebo placebo per os
3: Active Comparator ketoprofen 1 mg/Kg and placebo in single dose	Drug: placebo placebo per os Drug: ketoprofen ketoprofen 1 mg/Kg

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557544

Contacts

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

Locations

Italy
Edoardo Guglia
Trieste, Italy, 34100

Sponsors and Collaborators

IRCCS Burlo Garofolo

Investigators

Principal Investigator:

Edoardo Guglia, MD

IRCCS Burlo Garofolo

More Information

No publications provided

Responsible Party:	Edoardo Guglia ( IRCCS Burlo Garofolo )
Study ID Numbers:	rc 32/07
Study First Received:	November 13, 2007
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00557544 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by IRCCS Burlo Garofolo:

migraine
metoclopramide
ketoprofen
child

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ketoprofen
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antiemetics
Headache Disorders, Primary
Brain Diseases
Metoclopramide
Headache Disorders
Sensory System Agents
Migraine Disorders
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal

Analgesics
Nervous System Diseases
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Central Nervous System Diseases
Dopamine Antagonists
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009