NCT04252521

Brief 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 sound, interfering with daily activities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 3, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

January 31, 2020

Last Update Submit

February 7, 2024

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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

    15 minutes and 30 minutes after the study drug administered

Secondary Outcomes (2)

  • Adverse events

    30 minutes after

  • need to rescue medication

    30 minutes after

Study Arms (3)

metoclopramide+ dexketoprofen trometamol

ACTIVE COMPARATOR

10 mg metoclopramide+ 50 mg dexketoprofen trometamol

Drug: metoclopramide+dexketoprofen trometamol

metoclopramide

EXPERIMENTAL

10 mg metoclopramide

Drug: metoclopramide

dexketoprofen trometamol

EXPERIMENTAL

50 mg dexketoprofen trometamol

Drug: dexketoprofen trometamol

Interventions

metoclopramideDRUG

10 mg Metpamid in 100 ml normal saline solution

Also known as: Metpamid (metoclopramide)
metoclopramide
dexketoprofen trometamolDRUG

50 mg dexketoprofen trometamol in 100 ml normal saline solution

Also known as: Metadem (dexketoprofen trometamol)
dexketoprofen trometamol
metoclopramide+dexketoprofen trometamolDRUG

10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution

Also known as: Metpamid+Metadem
metoclopramide+ dexketoprofen trometamol

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 and over with acute headache who met the diagnostic criteria of the International Headache Association (9) for the diagnosis of migraine

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adiyaman University Research Hospital

Adıyaman, Central, 02000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 24818542BACKGROUND

  • Yang 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.

    PMID: 31725614BACKGROUND

  • Yavuz 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.

    PMID: 32359776DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Metoclopramidedexketoprofen trometamol

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 EthersPhenols

Study Officials

  • Umut Gülaçtı

    Adiyaman University of Medical Faculty

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

July 3, 2019

Primary Completion

January 3, 2020

Study Completion

January 3, 2020

Last Updated

February 8, 2024

Record last verified: 2024-02

Locations

TU(1)