Migraine DisordersPhase 2NCT01791400
Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache
A Phase 2 study testing metoclopramide, injection,20mg, one time and Sumatriptan, injection, 6 mg, one time in people with Migraine Disorders, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine which drug makes lower migraine headache Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- metoclopramide, injection,20mg, one time and Sumatriptan, injection, 6 mg, one time
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIran
- Study dates
- Jul 2009to Nov 2010
- Phase
- Phase 2
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-60 years old and presented with acute headache similar to previous episodes,
- with or without phonophobia,
- photophobia,
- vomiting or nausea.
Who cannot join
- fever or neck stiffness,
- altered mental state,
- pregnancy,
- recent trauma or seizure (within 24 hours),
- focal neurological abnormality on physical examination,
- allergy to metoclopramide,
Show all 9Show fewer
- hypertension,
- cardiovascular diseases.
- Also if the patients had taken a triptan or ergot during the last 24 hours were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache
The purpose of this study is to determine which drug makes lower migraine headache
Read the detailed description
There are different options to manage benign headache in emergency department.The investigators compared Intravenous metoclopramide with Subcutaneous sumatriptan to relieve pain in emergency department.
- Conditions
- Migraine Disorders
- Being tested
- metoclopramide, injection,20mg, one time, Sumatriptan, injection, 6 mg, one time
- Keywords
- Metoclopramide, Sumatriptan, migraine, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metoclopramide, injection,20mg, one timeDrug
Also called plasil
metoclopramide, intravenous injection,20mg, one time
Sumatriptan, injection, 6 mg, one timeDrug
Sumatriptan, subcutaneous injection, 6 mg, one time
| Study group | Role | What they receive |
|---|---|---|
| sumatriptan | Other | Patients who underwent 6 mg sumatriptan subcutaneous one time Receives: Drug: Sumatriptan, injection, 6 mg, one time |
| Metoclopramide | Other | Patients who underwent 20 mg Metoclopramide intravenous one time Receives: Drug: metoclopramide, injection,20mg, one time |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
determining pain in Metoclopramide versus sumatriptan groups
Measured: at one hour after prescription
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Shemshaki, Isfahan University of Medical Sciences
- Investigators
- babak masoumi, A.Professor, Principal investigator, Isfahan, Isfahan, Iran, Islamic Republic of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791400
- Sponsor's protocol ID
- ASD-1213-70
- Status last verified
- Feb 2013
- First submitted
- 10 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Effects of Metoclopramide Versus Sumatriptan on Migraine Headache
- ClinicalTrials.gov ID
- NCT01791400
- Acronym / sponsor ID
- ASD-1213-70
- Conditions
- Migraine Disorders
- Keywords
- Metoclopramide, Sumatriptan, migraine, headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 15 Feb 2013 (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.
The purpose of this study is to determine which drug makes lower migraine headache
Detailed description
There are different options to manage benign headache in emergency department.The investigators compared Intravenous metoclopramide with Subcutaneous sumatriptan to relieve pain in emergency department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sumatriptan | Other | Drug: Sumatriptan, injection, 6 mg, one timePatients who underwent 6 mg sumatriptan subcutaneous one time |
| Metoclopramide | Other | Drug: metoclopramide, injection,20mg, one timePatients who underwent 20 mg Metoclopramide intravenous one time |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 20-60 years old and presented with acute headache similar to previous episodes,
- with or without phonophobia,
- photophobia,
- vomiting or nausea.
Key exclusion criteria (9 listed)
- fever or neck stiffness,
- altered mental state,
- pregnancy,
- recent trauma or seizure (within 24 hours),
- focal neurological abnormality on physical examination,
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 |
|---|---|---|
| metoclopramide, injection,20mg, one timeAlso: plasilmetoclopramide, intravenous injection,20mg, one time | Drug | Metoclopramide |
| Sumatriptan, injection, 6 mg, one timeSumatriptan, subcutaneous injection, 6 mg, one time | Drug | sumatriptan |
Primary outcome
pain
Time frame: at one hour after prescription
determining pain in Metoclopramide versus sumatriptan groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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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.
babak masoumi, A.Professor principal investigator
Isfahan, Isfahan, Iran, Islamic Republic of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing metoclopramide, injection,20mg, one time and Sumatriptan, injection, 6 mg, one time in people with Migraine Disorders, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 15 Feb 2013. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pain (time frame: at one hour after prescription). 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 15 Feb 2013.