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Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00557544
First Posted: November 14, 2007
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IRCCS Burlo Garofolo
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

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 ]
  • need of a rescue drug for lack of effect in every arms of the trial [ Time Frame: 2 hours and 24 hours for relapses ]

Enrollment: 0
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00557544


Locations
Italy
Edoardo Guglia
Trieste, Italy, 34100
Sponsors and Collaborators
IRCCS Burlo Garofolo
Investigators
Principal Investigator: Edoardo Guglia, MD IRCCS Burlo Garofolo
  More Information

Responsible Party: IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00557544     History of Changes
Other Study ID Numbers: rc 32/07
First Submitted: November 13, 2007
First Posted: November 14, 2007
Last Update Posted: August 24, 2017
Last Verified: August 2017

Keywords provided by IRCCS Burlo Garofolo:
migraine
metoclopramide
ketoprofen
child

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metoclopramide
Ketoprofen
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors