Status:
COMPLETED
Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Migraine Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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, an...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1889 Patients enrolled
Trial Details
Trial ID
NCT02183688
Start Date
September 1 1998
Last Update
July 8 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.