NCT04533568

Brief Summary

In this study, the investigators planned to compare the effectiveness of an intravenous ibuprofen against an intravenous dexketoprofen among patients (18-65 years) who were admitted to the emergency department (ED) with acute migraine-related headaches and diagnosed migraine without aura. In this study, patients who presented with migraine-related headache to emergency departments will be included in this study. Two different therapy option are created; first, 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl , second, 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl. Patients's headache scores will be measured with visual analog score (VAS) at the pretreatment and post-treatment periods (0. minutes, 30. minutes, and 60. minutes.) 60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache score does not decrease by more than 50% from pretreatment-VAS score.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2020

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

First Submitted

Initial submission to the registry

August 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

August 22, 2020

Last Update Submit

December 12, 2021

Conditions

Migraine Without Aura

Keywords

migraine without migraineintravenous ibuprofenintravenous dexketoprofen

Outcome Measures

Primary Outcomes (1)

  • Resolving of Headache at 60 minute

    Patients's headache scores will be measured by using Visual Analog Scale (VAS). This scale ranged from 0mm (no pain) to 100mm (worst pain). Measurements will be performed at pre-treatment period and 60th minute after treatments.

    60 minutes after treatment - Change from Baseline Visual Analog Scale at 60th minutes

Secondary Outcomes (3)

  • Resolving of Headache at 30 minute

    30 minutes after treatment-Change from Baseline Visual Analog Scale at 30th minutes

  • Needing of rescue treatment

    60 minutes after treatment

  • Side and adverse effects

    From start of performing drug to in the first 24 hours after drug administration

Study Arms (2)

ibuprofen

EXPERIMENTAL

400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

Drug: Ibuprofen 400 mg

dexketoprofen

EXPERIMENTAL

50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

Drug: Dexketoprofen

Interventions

Ibuprofen 400 mgDRUG

400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

ibuprofen
DexketoprofenDRUG

50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.

dexketoprofen

Eligibility Criteria

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

You may qualify if:

  • All the patients aged 18-65 years who had been admitted to the ED for headaches and diagnosed acute migraine-related headache according to the International Classification of Headache Disorders-2018 edition
  • Patients whose pre-treatment VAS scores are more than 40 point.
  • Patients who give written and verbal consent to include study.

You may not qualify if:

  • Patients had taken any analgesic drugs or drugs for migraine prophylaxis in the last 6 hours
  • Patients had a history of allergy to any of the drugs used in this study
  • Patients used any anticoagulant-agents,
  • Patients had bleeding diathesis
  • patients were pregnant,
  • patients were breastfeeding mothers
  • Patients who had chronic heart disease, chronic liver disease, and chronic kidney disease
  • Patients had peptic ulcer
  • Patients had a history of acute akathisia or acute dystonia to metoclopramide hcl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kecioren Training and Research Hospital

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine without Aura

Interventions

Ibuprofendexketoprofen trometamol

Condition Hierarchy (Ancestors)

Migraine DisordersHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
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
Associated Professor

Study Record Dates

First Submitted

August 22, 2020

First Posted

August 31, 2020

Study Start

September 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 3, 2022

Record last verified: 2021-12

Locations

TU(1)