MigrainePhase 4NCT02159547
IV Dexketoprofen vs Placebo in Migranie Attack
A Phase 4 study testing Dexketoprofen and Normal Saline in people with Migraine, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Dexketoprofen and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2014to Aug 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients presented with headache who diagnosed as migraine attack according to the international headache society
Who cannot join
- denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Govermental Hospital
Antalya
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Dexketoprofen, Normal Saline
- Keywords
- migraine, emergency department, dexketoprofen, placebo
- Medical subject headings
- Migraine Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexketoprofenDrug
Also called Arveles
50 mg intravenous arveles in 50 ml saline in 5 minutes
Normal SalineOther
50 ml normal saline
| Study group | Role | What they receive |
|---|---|---|
| Dexketoprofen | Active comparator | 50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion. Receives: Drug: Dexketoprofen |
| normal slaline | Placebo comparator | 50 ml normal saline Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 minutes
Secondary outcomes (1)
Adverse Effects
The adverse effects is being recorded to the study form after the study drugs are administered at the 45th minutes.
Measured: 45th minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenker Eken, Akdeniz University
- Investigators
- Faruk Gungor, Pyhsician, Principal investigator, Antalya Training and Govermental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159547
- Sponsor's protocol ID
- 41/10
- Status last verified
- Jun 2015
- First submitted
- 31 May 2014
- Last updated
- 23 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24394884
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Comparing Dexketoprofen to Placebo in Migraine Attack
- ClinicalTrials.gov ID
- NCT02159547
- Acronym / sponsor ID
- 41/10
- Conditions
- Migraine
- Keywords
- migraine, emergency department, dexketoprofen, placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Posted 23 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexketoprofen | Active comparator | Drug: Dexketoprofen50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion. |
| normal slaline | Placebo comparator | Other: Normal Saline50 ml normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients presented with headache who diagnosed as migraine attack according to the international headache society
Key exclusion criteria (1 listed)
- denied to give inform concent, illiterate patients, chronic renal failure, taking NSAIDs during the last six hours, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexketoprofenAlso: Arveles50 mg intravenous arveles in 50 ml saline in 5 minutes | Drug | Dexketoprofen |
| Normal Saline50 ml normal saline | Other | normal slaline |
Primary outcome
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.
1 secondary outcome
Adverse Effects
Time frame: 45th minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24394884Turkcuer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faruk Gungor, Pyhsician principal investigator
Antalya Training and Govermental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexketoprofen and Normal Saline in people with Migraine, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Change (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2015.