IV Dexketoprofen vs Placebo in Migranie Attack
Study of Comparing Dexketoprofen to Placebo in Migraine Attack
1 other identifier
interventional
224
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2014
Shorter than P25 for phase_4
1 active site
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
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 31, 2014
CompletedFirst Posted
Study publicly available on registry
June 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
July 23, 2015
CompletedJuly 23, 2015
June 1, 2015
3 months
May 31, 2014
March 16, 2015
June 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale Change
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 Outcomes (1)
Adverse Effects
45th minutes
Study Arms (2)
Dexketoprofen
ACTIVE COMPARATOR50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
normal slaline
PLACEBO COMPARATOR50 ml normal saline
Interventions
50 mg intravenous arveles in 50 ml saline in 5 minutes
Eligibility Criteria
You may qualify if:
- patients presented with headache who diagnosed as migraine attack according to the international headache society
You may not qualify if:
- denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antalya Training and Govermental Hospital
Antalya, Turkey (Türkiye)
Related Publications (1)
Turkcuer I, Serinken M, Eken C, Yilmaz A, Akdag O, Uyan E, Kiray C, Elicabuk H. Intravenous paracetamol versus dexketoprofen in acute migraine attack in the emergency department: a randomised clinical trial. Emerg Med J. 2014 Mar;31(3):182-5. doi: 10.1136/emermed-2013-203044. Epub 2014 Jan 6.
PMID: 24394884BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cenker EKEN
- Organization
- Akdeniz University
Study Officials
- PRINCIPAL INVESTIGATOR
Faruk Gungor, Pyhsician
Antalya Training and Govermental Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Proffesor
Study Record Dates
First Submitted
May 31, 2014
First Posted
June 10, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
July 23, 2015
Results First Posted
July 23, 2015
Record last verified: 2015-06