Migraine DisordersPhase 3NCT02183688
Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients
A Phase 3 study testing Low dose ASA, High dose ASA and Low dose paracetamol in people with Migraine Disorders, run by Boehringer Ingelheim.
Trial summary
To confirm the combination rationale for the combination of ASA + paracetamol + caffeine compared with the combination of ASA + paracetamol and the individual substances ASA, paracetamol, caffeine, and placebo administered orally to headache patients for two headache episodes 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?
- Low dose ASA, High dose ASA and Low dose paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,889 participants
- Where
- No sites listed yet
- Study dates
- Sep 1998to Jan 2003
- 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
- Female or male out-patients aged between 18 and 65 years
- Diagnosis: Headache
- Tension type headache according to international headache society (IHS) Headache Classification 2.1 (2.1.1 and 2.1.2) and/or
- Migraine according to IHS Headache Classification 1.1, 1.2.1 or
- Either a) or b), but cannot be distinctly classified
- The patient normally treats his/her headache successfully with non-prescription analgesics
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- He/She has been suffering from headache for 12 months at least
- The headache first occurred before the age of 50 years
- During the previous three months, the patient has suffered from headache twice a month at least
- Informed consent according to §§ 40, 41 of the german medicines act and Good Clinical Practice (GCP)
- The patient seems likely to comply
Who cannot join
- The patient treats his/her headache with prescription-only analgesics or migraine remedies
- The patient requires higher single doses of non-prescription analgesics to treat his/her headache than indicated in the patient information leaflet (e.g. more than 2 tablets of Thomapyrin tablets)
- The patient normally treats his/her headache with non-prescription analgesics in effervescent tablet form
- The patient normally takes his/her non-prescription analgesics immediately at the onset of the first signs of a headache episode
- Headache occurs on more than 10 days per month
- The typical, untreated headache normally lasts less than 4 hours without treatment
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- Women with a close association between the occurrence of headache and menstruation (menstrual migraine)
- Concomitant treatment with prescription-only and/or non-prescription analgesics
- Previous or concomitant treatment with antidepressants or antipsychotic medicines (previous treatment = within the previous 4 weeks)
- Previous or concomitant treatment with anti-rheumatic or anti-inflammatory drugs that may influence the headache symptoms (previous treatment = within the previous 4 days)
- Treatment of concomitant illnesses with drugs containing ASA (above a daily dose of 100 mg per day), paracetamol or caffeine (e.g. for feverish common cold, etc.)
- Migraine prophylaxis or administration of drugs, indicated for any other reasons that influence headache symptoms, e.g.
- Propanolol, Metoprolol, Flunarizine, Cyclandelate, Valproic acid, Serotonin antagonists (pizotifen, methysergide, lisuride), Ergotamine, Dihydroergotamine, Benzodiazepines, Magnesium, Monoamine oxidase inhibitors
- Concomitant treatments with anti-emetics
- Drug abuse connected with the headache (defined as the administration of analgesics or other drugs for the treatment of acute headache on more than 10 days per month)
- Alcohol or drug abuse as defined by diagnostic and statistical manual of mental disorders (DSM-IV)
- Pregnancy and lactation
- Gastrointestinal ulcers
- Pathologically increased bleeding tendency
- Glucose-6-phosphate dehydrogenase deficiency
- Hypersensitivity to paracetamol, caffeine, ASA, salicylates, and other anti-inflammatory/anti-rheumatic agents or other allergenic substances that are relevant to the clinical trial
- Bronchial asthma
- Concomitant treatment with anticoagulants (e.g. coumarin derivates, heparin)
- Clinically relevant chronic or recurrent gastrointestinal symptoms
- Clinically relevant liver disorders
- Clinically relevant pre-existing renal damage
- Gilbert's syndrome
- Not successfully treated hyperthyroidism
- Simultaneous participation in another clinical trial
- Participation in another clinical trial within 4 weeks of entering this study
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial to Confirm the Rationale of the ASA + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients
To confirm the combination rationale for the combination of ASA + paracetamol + caffeine compared with the combination of ASA + paracetamol and the individual substances ASA, paracetamol, caffeine, and placebo administered orally to headache patients for two headache episodes
- Conditions
- Migraine Disorders
- Being tested
- Low dose ASA, High dose ASA, Low dose paracetamol, High dose paracetamol, Caffeine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose ASADrug
High dose ASADrug
Low dose paracetamolDrug
High dose paracetamolDrug
CaffeineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| ASA + paracetamol + caffeine | Experimental | Not described Receives: Drug: Low dose ASA; Drug: Low dose paracetamol; Drug: Caffeine |
| ASA + paracetamol | Active comparator | Not described Receives: Drug: Low dose ASA; Drug: Low dose paracetamol |
| ASA | Active comparator | Not described Receives: Drug: High dose ASA |
| Paracetamol | Active comparator | Not described Receives: Drug: High dose paracetamol |
| Caffeine | Active comparator | Not described Receives: Drug: Caffeine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculated time to 50% pain relief, based on the pain intensity evaluated on a visual analogue scale (VAS)
Measured: 30 min., 1, 2, 3 and 4 hours after administration of the study medication
Secondary outcomes (10)
Percentage of patients with 50 % pain relief, evaluated on a VAS
Measured: At least 2 hours after administration of the study medication
Percentage of patients with 50 % pain relief, evaluated on a VAS
Measured: At least 30 min., 1, 3, and 4 hours after administration of the study medication
Pain intensity, evaluated on a VAS
Measured: 30 min., 1, 2, 3 and 4 hours after administration of the study medication
Ratio of weighted sum of pain intensity difference scores to maximum achievable sum of pain intensity differences (%SPIDweighted), evaluated on a VAS
Measured: Up to the end of the study
Extent of impairment of daily activities, evaluated on a 4-grade verbal scale (VRS)
Measured: Before, 30 min., 1, 2, 3 and 4 hours after administration of study drug
Duration of headache
Measured: Up to 48 hours after onset of each headache episode
Global assessment of efficacy by the patient, evaluated on a 4-grade VRS
Measured: Within 12 hours after study drug administration
Global assessment of tolerability by the patient, evaluated on a 4-grade VRS
Measured: Within 12 hours after study drug administration
Number of patients with adverse events
Measured: Up to the end of the study
Global assessment of tolerability by the investigator, evaluated on a 4-grade VRS
Measured: After each administration of study drug during the treatment phase
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 startSep 1998
- Primary completionJan 2003
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
- 1,889 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
- NCT02183688
- Sponsor's protocol ID
- 155.8
- Status last verified
- Jul 2014
- First submitted
- 7 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 Double-blind, Randomized, Placebo-controlled Clinical Trial to Confirm the Rationale of the ASA + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients
- ClinicalTrials.gov ID
- NCT02183688
- Acronym / sponsor ID
- 155.8
- Conditions
- Migraine Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,889 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 1998
- Primary completion
- Jan 2003 (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.
To confirm the combination rationale for the combination of ASA + paracetamol + caffeine compared with the combination of ASA + paracetamol and the individual substances ASA, paracetamol, caffeine, and placebo administered orally to headache patients for two headache episodes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ASA + paracetamol + caffeine | Experimental | Drug: Low dose ASA, Drug: Low dose paracetamol, Drug: Caffeine |
| ASA + paracetamol | Active comparator | Drug: Low dose ASA, Drug: Low dose paracetamol |
| ASA | Active comparator | Drug: High dose ASA |
| Paracetamol | Active comparator | Drug: High dose paracetamol |
| Caffeine | Active comparator | Drug: Caffeine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female or male out-patients aged between 18 and 65 years
- Diagnosis: Headache
- The patient normally treats his/her headache successfully with non-prescription analgesics
- He/She has been suffering from headache for 12 months at least
- The headache first occurred before the age of 50 years
Key exclusion criteria (30 listed)
- The patient treats his/her headache with prescription-only analgesics or migraine remedies
- The patient requires higher single doses of non-prescription analgesics to treat his/her headache than indicated in the patient information leaflet (e.g. more than 2 tablets of Thomapyrin tablets)
- The patient normally treats his/her headache with non-prescription analgesics in effervescent tablet form
- The patient normally takes his/her non-prescription analgesics immediately at the onset of the first signs of a headache episode
- Headache occurs on more than 10 days per month
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 |
|---|---|---|
| Low dose ASA | Drug | ASA + paracetamol, ASA + paracetamol + caffeine |
| High dose ASA | Drug | ASA |
| Low dose paracetamol | Drug | ASA + paracetamol, ASA + paracetamol + caffeine |
| High dose paracetamol | Drug | Paracetamol |
| Caffeine | Drug | ASA + paracetamol + caffeine, Caffeine |
| Placebo | Drug | Placebo |
Primary outcome
Calculated time to 50% pain relief, based on the pain intensity evaluated on a visual analogue scale (VAS)
Time frame: 30 min., 1, 2, 3 and 4 hours after administration of the study medication
10 secondary outcomes
Percentage of patients with 50 % pain relief, evaluated on a VAS
Time frame: At least 2 hours after administration of the study medication
Percentage of patients with 50 % pain relief, evaluated on a VAS
Time frame: At least 30 min., 1, 3, and 4 hours after administration of the study medication
Pain intensity, evaluated on a VAS
Time frame: 30 min., 1, 2, 3 and 4 hours after administration of the study medication
Ratio of weighted sum of pain intensity difference scores to maximum achievable sum of pain intensity differences (%SPIDweighted), evaluated on a VAS
Time frame: Up to the end of the study
Extent of impairment of daily activities, evaluated on a 4-grade verbal scale (VRS)
Time frame: Before, 30 min., 1, 2, 3 and 4 hours after administration of study drug
Duration of headache
Time frame: Up to 48 hours after onset of each headache episode
Global assessment of efficacy by the patient, evaluated on a 4-grade VRS
Time frame: Within 12 hours after study drug administration
Global assessment of tolerability by the patient, evaluated on a 4-grade VRS
Time frame: Within 12 hours after study drug administration
Number of patients with adverse events
Time frame: Up to the end of the study
Global assessment of tolerability by the investigator, evaluated on a 4-grade VRS
Time frame: After each administration of study drug during the treatment phase
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 Low dose ASA, High dose ASA and Low dose paracetamol 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 11 inclusion and 30 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?
Calculated time to 50% pain relief, based on the pain intensity evaluated on a visual analogue scale (VAS) (time frame: 30 min., 1, 2, 3 and 4 hours after administration of the study medication). 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.