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| Sponsored by: |
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:
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 |
|
Child Migraine |
Drug: metoclopramide and ketoprofen Drug: metoclopramide and placebo Drug: ketoprofen and placebo |
Phase III |
| Genetics Home Reference related topics: | familial hemiplegic migraine |
| MedlinePlus related topics: | Migraine |
| ChemIDplus related topics: | Ketoprofen Metoclopramide Metoclopramide hydrochloride |
| 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2010 |
| Arms | Assigned Interventions |
|
1: Experimental
metoclopramide 0,15 mg + ketoprofen 1 mg/kg per os
|
Drug: metoclopramide and ketoprofen
metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
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2: Active Comparator
metoclopramide and placebo
|
Drug: metoclopramide and ketoprofen
metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
Drug: metoclopramide and placebo
metoclopramide 0,15 mg/Kg + placebo per os
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3: Active Comparator
ketoprofen and placebo
|
Drug: ketoprofen and placebo
ketoprofen 1 mg/Kg and placebo in single dose
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Eligibility
| Ages Eligible for Study: | 6 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Edoardo Guglia, MD | +390403785373 | edigugl@gmail.com |
| Contact: Federico Minen, MD | +390403785263 | angela.decunto@libero.it |
| Italy | |||||
| Edoardo Guglia | Not yet recruiting | ||||
| Trieste, Italy, 34100 | |||||
| Contact: angela De Cunto, MD +390403785333 angela.decunto@libero.it | |||||
| Contact: Patrizia Salierno, MD +390403785373 patty76@aliceposta.it | |||||
| IRCCS Burlo Garofolo |
| Principal Investigator: | Edoardo Guglia, MD | IRCCS Burlo Garofolo |
More Information
| Study ID Numbers: | rc 32/07 |
| First Received: | November 13, 2007 |
| Last Updated: | November 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00557544 |
| Health Authority: | Italy: Ethics Committee |
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