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Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

Primary Purpose

Migraine

Status
Withdrawn
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
metoclopramide
placebo
ketoprofen
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, metoclopramide, ketoprofen, child

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Edoardo Guglia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose

metoclopramide 0,15 mg/Kg + placebo per os

ketoprofen 1 mg/Kg and placebo in single dose

Outcomes

Primary Outcome Measures

evaluation of healing times from pain in the 3 groups

Secondary Outcome Measures

comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial
need of a rescue drug for lack of effect in every arms of the trial

Full Information

First Posted
November 13, 2007
Last Updated
August 23, 2017
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT00557544
Brief Title
Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
Official Title
Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, metoclopramide, ketoprofen, child

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose
Arm Title
2
Arm Type
Active Comparator
Arm Description
metoclopramide 0,15 mg/Kg + placebo per os
Arm Title
3
Arm Type
Active Comparator
Arm Description
ketoprofen 1 mg/Kg and placebo in single dose
Intervention Type
Drug
Intervention Name(s)
metoclopramide
Intervention Description
metoclopramide 0,15 mg/kg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo per os
Intervention Type
Drug
Intervention Name(s)
ketoprofen
Intervention Description
ketoprofen 1 mg/Kg
Primary Outcome Measure Information:
Title
evaluation of healing times from pain in the 3 groups
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
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
Title
need of a rescue drug for lack of effect in every arms of the trial
Time Frame
2 hours and 24 hours for relapses

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edoardo Guglia, MD
Organizational Affiliation
IRCCS Burlo Garofolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edoardo Guglia
City
Trieste
ZIP/Postal Code
34100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

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