Acute Migraine HeadachePhase 4NCT03145467
Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine in Emergency Department
A Phase 4 study testing Paracetamol and Zolmitriptan in people with Acute Migraine Headache, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Migraine Headache
- What is being tested?
- Paracetamol and Zolmitriptan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2016to Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 were eligible for inclusion if they were aged 18 years or older, 65 years or younger
- 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
Who cannot join
- 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
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- 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
- Patients with arrhythmia accompanying Wolff-Parkinson-White syndrome or accessory conduits in the heart
- Patients with Glucose 6 Phosphate Dehydrogenase (G6PD) deficiency
- Those with other systemic diseases,
- Patients with a Visual Analogue Scale (VAS) pain score less than 50 mm
- Illiterates and patients with vision problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine Headache in Emergency Department: Randomize Controlled Trial
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.
Read the detailed description
- This is prospective, randomized, controlled research to compare the efficacy of these two drugs in emergancy department.
- The clinical trial was conducted in the ED of Pamukkale University Medical Faculty Hospital.
- Study personnel (emergency physicians and nurses) were trained before the study.
- When oral drugs (paracetamol, zolmitriptan was being recommended, an eligibility checklist was completed by the attending physician.
- If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial headache pain score ratings with VAS and NRS were recorded.
- The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
- All patients eligible for the study were randomized to one of two groups:
- First Group: paracetamol 1000 mg was given oral to 100 patients,
- Second Group: Zolmitriptan 2,5 mg was given oral to 100 patients which determined to be applied as a group.
- Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations.
- The allocation list was kept by the emergency nurse. Patients received the paracetamol, zolmitriptan medication schemes according to their random allocations.
- After enrollment and recording of baseline information, the next numbered study drug was obtained, and administered as oral.
- Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
- One researcher blinded to patient allocation observed the whole procedure and recorded the Headache scores.
- Headache scores were recorded at 0, 15, 30, and 60 min on a VAS of 1 to 100 mm and NRS of 1 to 10. Patients with nausea are treated with 15 minutes of 10 mg metoclorpramide slow infusion in 150 cc saline solution.
- Rescue medication (1 mcg/kg fentanyl ) was given İntravenöz to patients if pain VAS scores ≥ 50 mm in 60 minutes after study drug administration.
- All other medications required during the study also were recorded.
- During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.
- Conditions
- Acute Migraine Headache
- Being tested
- Paracetamol, Zolmitriptan
- Keywords
- Migraine, Paracetamol, Zolmitriptan, Emergency services
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Parol
1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients
ZolmitriptanDrug
Also called Zomig
Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Experimental | 1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients Receives: Drug: Paracetamol |
| Zolmitriptan | Experimental | Second Group: Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients. Receives: Drug: Zolmitriptan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrement of the pain on VAS
- Compare decrease of migraine headache VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)
Measured: Change from baseline in migraine headache VAS score at 60 minutes
Decrement of the pain on NRS
- Compare decrease of migraine headache NRS (Numeric Rating Scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)
Measured: Change from baseline in migraine headache NRS score at 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study startJan 2016
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Migraine HeadacheStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Turkcuer, Pamukkale University
- Investigators
- Cuneyt Arikan, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145467
- Sponsor's protocol ID
- 2015TPF039
- Status last verified
- May 2017
- First submitted
- 21 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Paracetamol and Zolmitriptan Efficacy in the Treatment of Acute Migraine Headache in Emergency Department: Randomize Controlled Trial
- ClinicalTrials.gov ID
- NCT03145467
- Acronym / sponsor ID
- 2015TPF039
- Conditions
- Acute Migraine Headache
- Keywords
- Migraine, Paracetamol, Zolmitriptan, Emergency services
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- This is prospective, randomized, controlled research to compare the efficacy of these two drugs in emergancy department.
- The clinical trial was conducted in the ED of Pamukkale University Medical Faculty Hospital.
- Study personnel (emergency physicians and nurses) were trained before the study.
- When oral drugs (paracetamol, zolmitriptan was being recommended, an eligibility checklist was completed by the attending physician.
- If there were no exclusion criteria, written informed consent was obtained and baseline information, including initial headache pain score ratings with VAS and NRS were recorded.
- The need for identification and enrollment of participants by staff with conflicting work pressures resulted in recruitment of a convenience sample of patients.
- All patients eligible for the study were randomized to one of two groups:
- First Group: paracetamol 1000 mg was given oral to 100 patients,
- Second Group: Zolmitriptan 2,5 mg was given oral to 100 patients which determined to be applied as a group.
- Drugs were prepared according to the computer-generated random number sequence to assign treatment allocations.
- The allocation list was kept by the emergency nurse. Patients received the paracetamol, zolmitriptan medication schemes according to their random allocations.
- After enrollment and recording of baseline information, the next numbered study drug was obtained, and administered as oral.
- Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms)
- One researcher blinded to patient allocation observed the whole procedure and recorded the Headache scores.
- Headache scores were recorded at 0, 15, 30, and 60 min on a VAS of 1 to 100 mm and NRS of 1 to 10. Patients with nausea are treated with 15 minutes of 10 mg metoclorpramide slow infusion in 150 cc saline solution.
- Rescue medication (1 mcg/kg fentanyl ) was given İntravenöz to patients if pain VAS scores ≥ 50 mm in 60 minutes after study drug administration.
- All other medications required during the study also were recorded.
- During the study, pulse rate, systolic blood pressure, diastolic blood pressure, respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and 60 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: Paracetamol1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients |
| Zolmitriptan | Experimental | Drug: ZolmitriptanSecond Group: Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
- 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
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| ParacetamolAlso: Parol1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients | Drug | Paracetamol |
| ZolmitriptanAlso: ZomigZolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients | Drug | Zolmitriptan |
Primary outcome
Decrement of the pain on VAS
Time frame: Change from baseline in migraine headache VAS score at 60 minutes
1. Compare decrease of migraine headache VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)
Decrement of the pain on NRS
Time frame: Change from baseline in migraine headache NRS score at 60 minutes
1. Compare decrease of migraine headache NRS (Numeric Rating Scale) score between the two groups. - (First group Paracetamol and Second Zolmitriptan)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Cuneyt Arikan, MD principal investigator
Pamukkale University
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 Paracetamol and Zolmitriptan in people with Acute Migraine Headache, run by Pamukkale 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 4 inclusion and 20 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 9 May 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decrement of the pain on VAS (time frame: Change from baseline in migraine headache VAS score at 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2017.