Migraine DisordersPhase 3NCT02183220
Efficacy and Tolerability of Metamizol in Patients With Episodic Moderate Headache
A Phase 3 study testing Metamizol and Acetylsalicylic acid (ASA) in people with Migraine Disorders, run by Boehringer Ingelheim.
Trial summary
The objective of the study was to evaluate the efficacy, safety and tolerability of a single peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid in 2 episodes of moderate tension headache. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Metamizol and Acetylsalicylic acid (ASA)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Jul 1999
- Phase
- Phase 3
- 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
- Male and female patients between 18 and 65 years old
- Moderate episodic tension headache according to International Headache Society (I.H.S.) classification 2.1 (2.1.1 and 2.1.2) for at least one year
- At least two episodes of tension headache per month in the last three months prior to enrolment into this trial
- The episodes of tension headaches were usually treated by the patient successfully with a non-opioid-analgesic
- First episodic headache occurred at an age under 50 years
- Written informed consent according to Good Clinical Practice (GCP) and local regulations
- The patient was able to fill in the Patient's Diary
Who cannot join
- The patient usually needs for successful treatment of tension headache "Over The Counter" (OTC) analgesic in doses exceeding the doses tested here
- The patient takes an OTC-analgesic normally at the first signs of an episode of tension headache
- The patient has more than 15 episodes of tension headache per month
- Female patients whose episodic tension headache is strongly correlated with the start of hormonal contraception
- Concomitant treatment with (non-) prescriptional analgesics
- Pre- (less than 4 weeks prior to inclusion in this trial) and/or concomitant treatment with an antidepressive and/or antipsychotic drug
Show all 21Show fewer
- Pre- (less than 2 weeks prior to inclusion in this trial) and/or concomitant treatment with any drug such as NSAIDs (Non-Steroidal Anti Inflammatory Drugs), propanolol, metroprolol, flunarizin, cyclandelate, valproic-acid, serotonergic antagonists, ergotamine, dihydroergotamines and benzodiazepines that may influence the headache symptomatology
- Use of benzodiazepines in the previous 24 hours to the administration of the study drug. Occasional use of benzodiazepines - up to 3 per week - is allowed
- Use of any drug with analgesic properties in the previous 24 hours to the administration of the study drug
- Concomitant treatment with any drug containing ASA and/or metamizol
- Concomitant treatment with anticoagulants such as heparin or coumarin-derivatives
- Alcohol and drug abuse according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders )
- Female patients in child-bearing age not using adequate means of birth control
- Pregnancy and/or lactation
- Gastrointestinal ulcers
- Liver and/or renal disease
- Bronchial asthma
- Relevant allergy or known hypersensitivity to the investigational drugs, its excipients and/or to other NSAIDs
- Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
- Patients with active gastroesophageal flux disease (Amendment number 1)
- Concomitant treatment with analgesics or any other drug that may have influenced the headache symptomatology - including metamizol or ASA -, was referred to its use during the headache episodes under evaluation. As long as appropriate wash-out periods were respected, analgesics were allowed in between the episodes of tension headache (TH) and their use as a rescue medication did not lead to the exclusion of the patient (Amendment number 2)
About this study
Official title: A Randomised, Double Blind, Placebo- and Active-controlled Parallel Group Study Investigating the Efficacy and Tolerability of Metamizol 0.5 g and 1.0 g in Patients With Episodic Moderate Tension Headache.
The objective of the study was to evaluate the efficacy, safety and tolerability of a single peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid in 2 episodes of moderate tension headache.
- Conditions
- Migraine Disorders
- Being tested
- Metamizol, Acetylsalicylic acid (ASA), Metamizol placebo, ASA placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetamizolDrug
Acetylsalicylic acid (ASA)Drug
Metamizol placeboDrug
ASA placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Metamizol high & Placebo | Experimental | Not described Receives: Drug: Metamizol; Drug: Metamizol placebo |
| Metamizol low & Placebo | Experimental | Not described Receives: Drug: Metamizol; Drug: Metamizol placebo |
| Acetylsalicylic acid & Placebo | Active comparator | Not described Receives: Drug: Acetylsalicylic acid (ASA); Drug: ASA placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Metamizol placebo; Drug: ASA placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS)
Measured: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Secondary outcomes (9)
Pain intensity difference (PID) on a VAS
Measured: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Maximum pain intensity difference (MAXPID) on a VAS
Measured: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Number of patients with at least a 50% pain reduction on a VAS
Measured: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Time to 50% pain intensity reduction on a VAS
Measured: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS)
Measured: 30 minutes, 1, 2, 3, and 4 hours after drug intake
Total pain relief (TOTPAR) on a VRS
Measured: 30 minutes, 1, 2, 3, and 4 hours after drug intake
Number of patients using rescue medication
Measured: 2, 3, and 4 hours after drug intake
Global efficacy assessment on a VRS by the patient and investigator
Measured: 4 hours after drug intake
Number of patients with adverse events
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startOct 1998
- Primary completionJul 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183220
- Sponsor's protocol ID
- 1093.16
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo- and Active-controlled Parallel Group Study Investigating the Efficacy and Tolerability of Metamizol 0.5 g and 1.0 g in Patients With Episodic Moderate Tension Headache.
- ClinicalTrials.gov ID
- NCT02183220
- Acronym / sponsor ID
- 1093.16
- Conditions
- Migraine Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Jul 1999 (actual)
- First posted
- 8 Jul 2014 (estimated)
- 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 objective of the study was to evaluate the efficacy, safety and tolerability of a single peroral dose of 0.5 g and 1.0 g metamizol relative to placebo and 1.0 g acetylsalicylic acid in 2 episodes of moderate tension headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metamizol high & Placebo | Experimental | Drug: Metamizol, Drug: Metamizol placebo |
| Metamizol low & Placebo | Experimental | Drug: Metamizol, Drug: Metamizol placebo |
| Acetylsalicylic acid & Placebo | Active comparator | Drug: Acetylsalicylic acid (ASA), Drug: ASA placebo |
| Placebo | Placebo comparator | Drug: Metamizol placebo, Drug: ASA placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients between 18 and 65 years old
- Moderate episodic tension headache according to International Headache Society (I.H.S.) classification 2.1 (2.1.1 and 2.1.2) for at least one year
- At least two episodes of tension headache per month in the last three months prior to enrolment into this trial
- The episodes of tension headaches were usually treated by the patient successfully with a non-opioid-analgesic
- First episodic headache occurred at an age under 50 years
Key exclusion criteria (21 listed)
- The patient usually needs for successful treatment of tension headache "Over The Counter" (OTC) analgesic in doses exceeding the doses tested here
- The patient takes an OTC-analgesic normally at the first signs of an episode of tension headache
- The patient has more than 15 episodes of tension headache per month
- Female patients whose episodic tension headache is strongly correlated with the start of hormonal contraception
- Concomitant treatment with (non-) prescriptional analgesics
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 |
|---|---|---|
| Metamizol | Drug | Metamizol high & Placebo, Metamizol low & Placebo |
| Acetylsalicylic acid (ASA) | Drug | Acetylsalicylic acid & Placebo |
| Metamizol placebo | Drug | Metamizol high & Placebo, Metamizol low & Placebo, Placebo |
| ASA placebo | Drug | Acetylsalicylic acid & Placebo, Placebo |
Primary outcome
Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS)
Time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
9 secondary outcomes
Pain intensity difference (PID) on a VAS
Time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Maximum pain intensity difference (MAXPID) on a VAS
Time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Number of patients with at least a 50% pain reduction on a VAS
Time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Time to 50% pain intensity reduction on a VAS
Time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake
Maximum pain relief (MAXPAR) on a Verbal Rating Scale (VRS)
Time frame: 30 minutes, 1, 2, 3, and 4 hours after drug intake
Total pain relief (TOTPAR) on a VRS
Time frame: 30 minutes, 1, 2, 3, and 4 hours after drug intake
Number of patients using rescue medication
Time frame: 2, 3, and 4 hours after drug intake
Global efficacy assessment on a VRS by the patient and investigator
Time frame: 4 hours after drug intake
Number of patients with adverse events
Time frame: up to 2 months
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 8 Jul 2014.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metamizol and Acetylsalicylic acid (ASA) in people with Migraine Disorders, run by Boehringer Ingelheim.
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 7 inclusion and 21 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time-interval weighted sum of pain intensity difference (SPID) on a Visual Analogue Scale (VAS) (time frame: before and 30 minutes, 1, 2, 3, and 4 hours after drug intake). 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 8 Jul 2014.