MigrainePhase 4NCT06786650
Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack
A Phase 4 study testing Tenoxicam Injectable Product and ibuprofen in people with Migraine and Analgesic Affect, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical trial is to compare the efficacy of two different non-steroidal anti-inflammatory analgesic drugs in the palliation of headache in acute migraine attack. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Analgesic Affect, Emergency Medicine
- What is being tested?
- Tenoxicam Injectable Product and ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 30 Jun 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Being between the ages of 18-65.
- Having a known diagnosis of migraine.
- Exclusion of secondary causes to explain the headache in the emergency department.
- Having migraine during a migraine attack and not having received any medical treatment for migraine before the application.
Who cannot join
- Being under 18 years of age.
- Being pregnant or breastfeeding.
- Being admitted to the emergency department with headache due to causes other than migraine (secondary).
- Being admitted with an acute migraine attack and having used medication for migraine treatment within 12 hours before admission.
- Having a history of allergy to any of the drugs to be used in the study.
- Having a history of comorbidities for which the drugs to be used in the study are contraindicated.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Training and Research Hospital
Istanbul, Uskudar, 34843
About this study
The aim of this clinical trial is to compare the efficacy of two different non-steroidal anti-inflammatory analgesic drugs in the palliation of headache in acute migraine attack. The main questions it aims to answer are:
- Is there a difference between the efficacy of two different nonsteroidal anti-inflammatory analgesics?
- Is there a significant difference between the side effects of two different nonsteroidal anti-inflammatory drugs? Researchers will compare intravenous tenoxicam to intravenous ibuprofen to see if tenoxicam works to treat migraine attack.
Read more
Treatments will;
- be administered in 100 cc saline to ensure blinding in the group.
- Randomisation will be done by closed envelope method.
- Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the drugs. NRS scores will be recorded in both groups before starting treatment (baseline) and at 30, 60 and 120 minutes after treatment.
- Any side effects due to medication will be recorded.
- Conditions
- Migraine, Analgesic Affect, Emergency Medicine
- Being tested
- Tenoxicam Injectable Product, ibuprofen
- Keywords
- Anti-Inflammatory Agents Non-Steroidal, Acute migrane attack
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenoxicam Injectable ProductDrug
Also called tenoxicam
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
ibuprofenDrug
Analgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before.
| Study group | Role | What they receive |
|---|---|---|
| Tenoxicam Group. IV Tenoxicam | Active comparator | Intravenous tenoxicam (20 mg) will be administered in 100 cc saline in 10 minutes to patients admitted to our emergency department with headache due to acute migraine attack. Receives: Drug: Tenoxicam Injectable Product |
| Ibuprofen Group. IV Ibuprofen | Sham comparator | Intravenous ibuprofen (400 mg) will be administered in 100 cc saline in 10 minutes to patients who present to our emergency department due to headache due to acute migraine attack. Receives: Drug: ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of pain palliation
The primary outcome of our study is the achievement of pain palliation. This will be defined as a ≥ 50% reduction in Numerical rating scale (NRS) scores after treatment compared to the baseline score (NRS Baseline). The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Mean and proportional reduction in NRS scores will also be analysed while evaluating the efficacy of the treatment.
Measured: NRS scores of both patient groups will be recorded at the time of admission (NRS Baseline) and at 30, 60 and 120 minutes after the treatment is given.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start15 May 2024
- Primary completion15 Oct 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Dogruyol, Haydarpasa Numune Training and Research Hospital
- Investigators
- Colak, Professor Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786650
- Sponsor's protocol ID
- 2024-KAEK-18
- Status last verified
- Jun 2025
- First submitted
- 29 Nov 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of the Analgesic Effects of Intravenous Ibuprofen and Tenoxicam in Acute Migraine Attack
- ClinicalTrials.gov ID
- NCT06786650
- Acronym / sponsor ID
- 2024-KAEK-18
- Conditions
- Migraine, Analgesic Affect, Emergency Medicine
- Keywords
- Anti-Inflammatory Agents Non-Steroidal, Acute migrane attack
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Jan 2025 (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.
The aim of this clinical trial is to compare the efficacy of two different non-steroidal anti-inflammatory analgesic drugs in the palliation of headache in acute migraine attack. The main questions it aims to answer are:
- Is there a difference between the efficacy of two different nonsteroidal anti-inflammatory analgesics?
- Is there a significant difference between the side effects of two different nonsteroidal anti-inflammatory drugs? Researchers will compare intravenous tenoxicam to intravenous ibuprofen to see if tenoxicam works to treat migraine attack.
Treatments will;
- be administered in 100 cc saline to ensure blinding in the group.
- Randomisation will be done by closed envelope method.
- Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the drugs. NRS scores will be recorded in both groups before starting treatment (baseline) and at 30, 60 and 120 minutes after treatment.
- Any side effects due to medication will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenoxicam Group. IV Tenoxicam | Active comparator | Drug: Tenoxicam Injectable ProductIntravenous tenoxicam (20 mg) will be administered in 100 cc saline in 10 minutes to patients admitted to our emergency department with headache due to acute migraine attack. |
| Ibuprofen Group. IV Ibuprofen | Sham comparator | Drug: ibuprofenIntravenous ibuprofen (400 mg) will be administered in 100 cc saline in 10 minutes to patients who present to our emergency department due to headache due to acute migraine attack. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being between the ages of 18-65.
- Having a known diagnosis of migraine.
- Exclusion of secondary causes to explain the headache in the emergency department.
- Having migraine during a migraine attack and not having received any medical treatment for migraine before the application.
Key exclusion criteria (6 listed)
- Being under 18 years of age.
- Being pregnant or breastfeeding.
- Being admitted to the emergency department with headache due to causes other than migraine (secondary).
- Being admitted with an acute migraine attack and having used medication for migraine treatment within 12 hours before admission.
- Having a history of allergy to any of the drugs to be used in the study.
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 |
|---|---|---|
| Tenoxicam Injectable ProductAlso: tenoxicamAnalgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before. | Drug | Tenoxicam Group. IV Tenoxicam |
| ibuprofenAnalgesic efficacy of the two active agents analysed in our study in acute migraine attack has not been compared before. | Drug | Ibuprofen Group. IV Ibuprofen |
Primary outcome
Achievement of pain palliation
Time frame: NRS scores of both patient groups will be recorded at the time of admission (NRS Baseline) and at 30, 60 and 120 minutes after the treatment is given.
The primary outcome of our study is the achievement of pain palliation. This will be defined as a ≥ 50% reduction in Numerical rating scale (NRS) scores after treatment compared to the baseline score (NRS Baseline). The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable". Mean and proportional reduction in NRS scores will also be analysed while evaluating the efficacy of the treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
Colak, Professor Dr principal investigator
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 Tenoxicam Injectable Product and ibuprofen in people with Migraine and Analgesic Affect, run by Haydarpasa Numune Training and Research Hospital 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 6 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Achievement of pain palliation (time frame: NRS scores of both patient groups will be recorded at the time of admission (NRS Baseline) and at 30, 60 and 120 minutes after the treatment is given.). 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 26 Jun 2025.