MigraineNCT04252521
Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine
A study testing metoclopramide, dexketoprofen trometamol and metoclopramide+dexketoprofen trometamol in people with Migraine, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Acute headache is one of the most common reasons for presentation to the emergency department (ED), accounting for 2-3% of all emergency visits. Migraine is a disorder of the central nervous system characterized by a moderate or severe headache, which is generally associated with nausea and/or sensitivity to light and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Migraine
- What is being tested?
- metoclopramide, dexketoprofen trometamol and metoclopramide+dexketoprofen trometamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2019to 3 Jan 2020
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients aged 18 and over with acute headache who met the diagnostic criteria of the International Headache Association (9) for the diagnosis of migraine
Who cannot join
- Patients who refused to participate in the study
- Patients that took any analgesic medication within six hours before presentation to ED Patients with any additional organic pathology (e.g., hypertension, hypoglycemia, chronic kidney failure, and intracranial masses) pregnant women hemodynamically unstable patients patients with an allergy to the drugs used in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adiyaman University Research Hospital
Adıyaman, Central, 02000
About this study
Official title: Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Acute Migraine Attack in the Emergency Department: a Randomized Double-blind Controlled Trial
Acute headache is one of the most common reasons for presentation to the emergency department (ED), accounting for 2-3% of all emergency visits. Migraine is a disorder of the central nervous system characterized by a moderate or severe headache, which is generally associated with nausea and/or sensitivity to light and sound, interfering with daily activities.
Read the detailed description
Study objective: The objective of this study is to determine the analgesic efficacy and safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to the emergency department (ED).
Methods of Measurements:
This single-center, randomized, double-blind study will be conducted in a tertiary care ED. Eligible patients who met the migraine criteria of the International Headache Society will be randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen trometamol, or 50 mg dexketoprofen trometamol + 10 mg metoclopramide.
Subjects reported pain intensity on both a 100-mm visual analogue scale (VAS) (limited by 'no pain' and 'the worst pain') will be used for pain measurement at baseline, after 15 and 30 min. The primary outcome measure is the changes in the VAS scores at the 15th and 30th minutes of treatment. The secondary outcome measures are the presence of adverse effects and the requirement of rescue medicine.
Primary Data Analysis:
The study was planned as a superiority trial. The difference in the VAS values between the groups was assumed to detect 21.4 mm and the standard deviation (SD) value as 2.8 mm, and thus the minimum required the number of patients for each group was calculated as 27 at the alpha-critical value of 0.05 and power of 80%. All the analyses were implemented according to the intention to treat analysis. Differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).
- Conditions
- Migraine
- Being tested
- metoclopramide, dexketoprofen trometamol, metoclopramide+dexketoprofen trometamol
- 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
Also called Metpamid (metoclopramide)
10 mg Metpamid in 100 ml normal saline solution
dexketoprofen trometamolDrug
Also called Metadem (dexketoprofen trometamol)
50 mg dexketoprofen trometamol in 100 ml normal saline solution
metoclopramide+dexketoprofen trometamolDrug
Also called Metpamid+Metadem
10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| metoclopramide+ dexketoprofen trometamol | Active comparator | 10 mg metoclopramide+ 50 mg dexketoprofen trometamol Receives: Drug: metoclopramide+dexketoprofen trometamol |
| metoclopramide | Experimental | 10 mg metoclopramide Receives: Drug: metoclopramide |
| dexketoprofen trometamol | Experimental | 50 mg dexketoprofen trometamol Receives: Drug: dexketoprofen trometamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the intensity of pain
Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 15th and 30th minutes later after the study drug administered
Measured: 15 minutes and 30 minutes after the study drug administered
Secondary outcomes (2)
Adverse events
30 minutes after the study drug administered
Measured: 30 minutes after
need to rescue medication
30 minutes after the study drug administered
Measured: 30 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start3 Jul 2019
- Primary completion3 Jan 2020
- Study completion3 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umut Gulacti, Adiyaman University Research Hospital
- Investigators
- Umut Gülaçtı, Principal investigator, Adiyaman University of Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252521
- Sponsor's protocol ID
- 66175679-514.04.01
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Egerton-Warburton D, Meek R, Mee MJ, Braitberg G. Antiemetic use for nausea and vomiting in adult emergency department patients: randomized controlled trial comparing ondansetron, metoclopramide, and placebo. Ann Emerg Med. 2014 Nov;64(5):526-532.e1. doi: 10.1016/j.annemergmed.2014.03.017. Epub 2014 May 10.
PubMed 24818542Yang B, Xu Z, Chen L, Chen X, Xie Y. The efficacy of dexketoprofen for migraine attack: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2019 Nov;98(46):e17734. doi: 10.1097/MD.0000000000017734.
PubMed 31725614Yavuz E, Gulacti U, Lok U, Turgut K. Intravenous metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in acute migraine attack in the emergency department: A randomized double-blind controlled trial. Am J Emerg Med. 2020 Nov;38(11):2254-2258. doi: 10.1016/j.ajem.2020.04.038. Epub 2020 Apr 15.
PubMed 32359776
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Acute Migraine Attack in the Emergency Department: a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04252521
- Acronym / sponsor ID
- 66175679-514.04.01
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- 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.
Acute headache is one of the most common reasons for presentation to the emergency department (ED), accounting for 2-3% of all emergency visits. Migraine is a disorder of the central nervous system characterized by a moderate or severe headache, which is generally associated with nausea and/or sensitivity to light and sound, interfering with daily activities.
Detailed description
Study objective: The objective of this study is to determine the analgesic efficacy and safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to the emergency department (ED).
Methods of Measurements:
This single-center, randomized, double-blind study will be conducted in a tertiary care ED. Eligible patients who met the migraine criteria of the International Headache Society will be randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen trometamol, or 50 mg dexketoprofen trometamol + 10 mg metoclopramide.
Subjects reported pain intensity on both a 100-mm visual analogue scale (VAS) (limited by 'no pain' and 'the worst pain') will be used for pain measurement at baseline, after 15 and 30 min. The primary outcome measure is the changes in the VAS scores at the 15th and 30th minutes of treatment. The secondary outcome measures are the presence of adverse effects and the requirement of rescue medicine.
Primary Data Analysis:
The study was planned as a superiority trial. The difference in the VAS values between the groups was assumed to detect 21.4 mm and the standard deviation (SD) value as 2.8 mm, and thus the minimum required the number of patients for each group was calculated as 27 at the alpha-critical value of 0.05 and power of 80%. All the analyses were implemented according to the intention to treat analysis. Differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).
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 |
|---|---|---|
| metoclopramide+ dexketoprofen trometamol | Active comparator | Drug: metoclopramide+dexketoprofen trometamol10 mg metoclopramide+ 50 mg dexketoprofen trometamol |
| metoclopramide | Experimental | Drug: metoclopramide10 mg metoclopramide |
| dexketoprofen trometamol | Experimental | Drug: dexketoprofen trometamol50 mg dexketoprofen trometamol |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients aged 18 and over with acute headache who met the diagnostic criteria of the International Headache Association (9) for the diagnosis of migraine
Key exclusion criteria (2 listed)
- Patients who refused to participate in the study
- Patients that took any analgesic medication within six hours before presentation to ED Patients with any additional organic pathology (e.g., hypertension, hypoglycemia, chronic kidney failure, and intracranial masses) pregnant women hemodynamically unstable patients patients with an allergy to the drugs used in the study
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 |
|---|---|---|
| metoclopramideAlso: Metpamid (metoclopramide)10 mg Metpamid in 100 ml normal saline solution | Drug | metoclopramide |
| dexketoprofen trometamolAlso: Metadem (dexketoprofen trometamol)50 mg dexketoprofen trometamol in 100 ml normal saline solution | Drug | dexketoprofen trometamol |
| metoclopramide+dexketoprofen trometamolAlso: Metpamid+Metadem10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution | Drug | metoclopramide+ dexketoprofen trometamol |
Primary outcome
Change of the intensity of pain
Time frame: 15 minutes and 30 minutes after the study drug administered
Pain intense will be measured by 100 mm visual analog scale (Zero; no pain and 100 mm; the worst pain) after 15th and 30th minutes later after the study drug administered
2 secondary outcomes
Adverse events
Time frame: 30 minutes after
need to rescue medication
Time frame: 30 minutes after
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 8 Feb 2024.
- Background: PubMed 24818542Egerton-Warburton D, Meek R, Mee MJ, Braitberg G. Antiemetic use for nausea and vomiting in adult emergency department patients: randomized controlled trial comparing ondansetron, metoclopramide, and placebo. Ann Emerg Med. 2014 Nov;64(5):526-532.e1. doi: 10.1016/j.annemergmed.2014.03.017. Epub 2014 May 10.
- Background: PubMed 31725614Yang B, Xu Z, Chen L, Chen X, Xie Y. The efficacy of dexketoprofen for migraine attack: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2019 Nov;98(46):e17734. doi: 10.1097/MD.0000000000017734.
- Derived from this study: PubMed 32359776Yavuz E, Gulacti U, Lok U, Turgut K. Intravenous metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in acute migraine attack in the emergency department: A randomized double-blind controlled trial. Am J Emerg Med. 2020 Nov;38(11):2254-2258. doi: 10.1016/j.ajem.2020.04.038. Epub 2020 Apr 15.
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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.
Umut Gülaçtı principal investigator
Adiyaman University of Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metoclopramide, dexketoprofen trometamol and metoclopramide+dexketoprofen trometamol in people with Migraine, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
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 2 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 8 Feb 2024. 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 Turkey (Türkiye). 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.
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?
Change of the intensity of pain (time frame: 15 minutes and 30 minutes after the study drug administered). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252521, which also lists 3 linked publications.
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 8 Feb 2024.