IV Dexketoprofen vs Placebo in Migranie Attack

June 27, 2015 updated by: Cenker Eken, Akdeniz University

Study of Comparing Dexketoprofen to Placebo in Migraine Attack

H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in emergency department.

H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine attack in emergency department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Migraine attack is one of the most leading causes presentations to emergency department. Patients with migraine attack seek urgent care to cease their pain. There are so many interventions defined in the medical literature that can be used in migraine attacks. However, as a IV drug, dexketoprofen; little known whether IV dexketoprofen is superior to placebo or not. In the present study we aimed to determine the effects of IV dexketoprofen in migraine attack in emergency department.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Antalya Training and Govermental Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients presented with headache who diagnosed as migraine attack according to the international headache society

Exclusion Criteria:

  • denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dexketoprofen
50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
Drug: Dexketoprofen
50 mg intravenous arveles in 50 ml saline in 5 minutes
Other Names:
  • Arveles
PLACEBO_COMPARATOR: normal slaline
50 ml normal saline
Other: Normal Saline
50 ml normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale Change
Time Frame: 45 minutes
Change from baseline in Visual Analogue Scale, 100 mm, at 45th minutes. Visual Analogue Scale is measurement tool scoring tool between 0 (no pain) and 100 mm (worst pain). Minimum clinically significant change in pain score is 13 or 16 mm.
45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Effects
Time Frame: 45th minutes
The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.
45th minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Principal Investigator: Faruk Gungor, Pyhsician, Antalya Training and Govermental Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

May 31, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (ESTIMATE)

June 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2015

Last Update Submitted That Met QC Criteria

June 27, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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