NCT00557544

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

November 13, 2007

Last Update Submit

August 23, 2017

Conditions

Migraine

Keywords

migrainemetoclopramideketoprofenchild

Outcome Measures

Primary Outcomes (1)

  • evaluation of healing times from pain in the 3 groups

    2 hours

Secondary Outcomes (2)

  • comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial

    2 and 24 hours respectively

  • need of a rescue drug for lack of effect in every arms of the trial

    2 hours and 24 hours for relapses

Study Arms (3)

1

EXPERIMENTAL

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

Drug: metoclopramideDrug: ketoprofen

2

ACTIVE COMPARATOR

metoclopramide 0,15 mg/Kg + placebo per os

Drug: metoclopramideDrug: placebo

3

ACTIVE COMPARATOR

ketoprofen 1 mg/Kg and placebo in single dose

Drug: placeboDrug: ketoprofen

Interventions

metoclopramideDRUG

metoclopramide 0,15 mg/kg

12
placeboDRUG

placebo per os

23
ketoprofenDRUG

ketoprofen 1 mg/Kg

13

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 6-17 years old with migraine presenting in emergency room

You may not qualify if:

  • Informed consensus not obtained
  • Occurring migraine still treated
  • Hemiplegic migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edoardo Guglia

Trieste, 34100, Italy

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

MetoclopramideKetoprofen

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsPhenylpropionates

Study Officials

  • Edoardo Guglia, MD

    IRCCS Burlo Garofolo

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2007

First Posted

November 14, 2007

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

August 24, 2017

Record last verified: 2017-08

Locations

IT(1)