MigrainePhase 3NCT00557544
Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood
A Phase 3 study testing metoclopramide and ketoprofen in people with Migraine, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine
- What is being tested?
- metoclopramide and ketoprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2009to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6-17 years old with migraine presenting in emergency room
Who cannot join
- Informed consensus not obtained
- Occurring migraine still treated
- Hemiplegic migraine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child
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
- Conditions
- Migraine
- Being tested
- metoclopramide, placebo, ketoprofen
- Keywords
- migraine, metoclopramide, ketoprofen, child
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoclopramideDrug
metoclopramide 0,15 mg/kg
placeboDrug
placebo per os
ketoprofenDrug
ketoprofen 1 mg/Kg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | metoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose Receives: Drug: metoclopramide; Drug: ketoprofen |
| 2 | Active comparator | metoclopramide 0,15 mg/Kg + placebo per os Receives: Drug: metoclopramide; Drug: placebo |
| 3 | Active comparator | ketoprofen 1 mg/Kg and placebo in single dose Receives: Drug: placebo; Drug: ketoprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of healing times from pain in the 3 groups
Measured: 2 hours
Secondary outcomes (2)
comparison of percentage of healing from acute migraine and of relapses of pain in the three arms of trial
Measured: 2 and 24 hours respectively
need of a rescue drug for lack of effect in every arms of the trial
Measured: 2 hours and 24 hours for relapses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startJun 2009
- Primary completionDec 2009 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edoardo Guglia, MD, Principal investigator, IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557544
- Sponsor's protocol ID
- rc 32/07
- Status last verified
- Aug 2017
- First submitted
- 13 Nov 2007
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effectiveness of Metoclopramide Alone or in Combination With Ketoprofen in Acute Migraine of Child
- ClinicalTrials.gov ID
- NCT00557544
- Acronym / sponsor ID
- rc 32/07
- Conditions
- Migraine
- Keywords
- migraine, metoclopramide, ketoprofen, child
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: metoclopramide, Drug: ketoprofenmetoclopramide 0,15 mg/kg and Ketoprofen 1 mg/Kg per os in single dose |
| 2 | Active comparator | Drug: metoclopramide, Drug: placebometoclopramide 0,15 mg/Kg + placebo per os |
| 3 | Active comparator | Drug: placebo, Drug: ketoprofenketoprofen 1 mg/Kg and placebo in single dose |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 6-17 years old with migraine presenting in emergency room
Key exclusion criteria (3 listed)
- Informed consensus not obtained
- Occurring migraine still treated
- Hemiplegic migraine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metoclopramidemetoclopramide 0,15 mg/kg | Drug | 1, 2 |
| placeboplacebo per os | Drug | 2, 3 |
| ketoprofenketoprofen 1 mg/Kg | Drug | 1, 3 |
Primary outcome
evaluation of healing times from pain in the 3 groups
Time frame: 2 hours
2 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edoardo Guglia, MD principal investigator
IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing metoclopramide and ketoprofen in people with Migraine, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of healing times from pain in the 3 groups (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.