Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department

NCT03145467 | Completed Phase 4 DMC

• 1 other identifier: 2015TPF039
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Migraine is a chronic and sometimes progressive disorder, characterized by headache, recurrent episodes, and other associated symptoms. Migraine is the most common cause of headache among patients who applied to emergency services. The purpose of the investigators is to compare the efficacy of oral paracetamol and zolmitriptan in the treatment of acute migraine headache in an emergency department.

Conditions

Acute Migraine Headache

Keywords

Migraine; Paracetamol; Zolmitriptan; Emergency services

Outcome Measures

Primary Outcomes (2)

• Decrement of the pain on VAS

  1\. Compare decrease of migraine headache VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)

  Change from baseline in migraine headache VAS score at 60 minutes

• Decrement of the pain on NRS

  1\. Compare decrease of migraine headache NRS (Numeric Rating Scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)

  Change from baseline in migraine headache NRS score at 60 minutes

Study Arms (2)

Paracetamol

EXPERIMENTAL

1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients

Drug: Paracetamol

Zolmitriptan

EXPERIMENTAL

Second Group: Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients.

Drug: Zolmitriptan

Interventions

Paracetamol DRUG

1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients

Also known as: Parol

Paracetamol

Zolmitriptan DRUG

Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients

Also known as: Zomig

Zolmitriptan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had acute migraine attack without aura
• VAS (visual analog scale) score \>50 mm , NRS (Numeric Rating Scale) score \>5
• Patients whose written consent is obtained by agreeing to participate in the study

You may not qualify if:

• Those who refuse to participate in the work
• Patients younger than 18 years or older than 65 years
• Those who use ergotamine derivative drugs in the last 24 hours
• Have received analgesics in the last 6 hours
• Patients with severe liver, kidney, lung and heart failure
• To have active peptic ulcer bleeding or perforation
• Have a history of upper gastrointestinal disease
• To be Pregnancy and breast-feeding
• Patients of childbearing age who are not using a birth control method.
• Allergy to medicines used in work
• Hemodynamically unstable patients
• Patients with renal transplantation
• Blood pressure uncontrolled hypertension patients
• Patients with cerebrovascular disease history
• Patients with ischemic heart disease or coronary spasm / printzmetal angina

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acetaminophen; zolmitriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Cuneyt Arikan, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 9, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)