Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients

Exclusion Criteria

• •1. The patient treats his/her headache with prescription-only analgesics or migraine remedies
• •2. 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)
• •3. The patient normally treats his/her headache with non-prescription analgesics in effervescent tablet form
• •4. The patient normally takes his/her non-prescription analgesics immediately at the onset of the first signs of a headache episode
• •5. Headache occurs on more than 10 days per month
• •6. The typical, untreated headache normally lasts less than 4 hours without treatment
• •7. Women with a close association between the occurrence of headache and menstruation (menstrual migraine)
• •8. Concomitant treatment with prescription-only and/or non-prescription analgesics
• •9. Previous or concomitant treatment with antidepressants or antipsychotic medicines (previous treatment = within the previous 4 weeks)
• •10. Previous or concomitant treatment with anti-rheumatic or anti-inflammatory drugs that may influence the headache symptoms (previous treatment = within the previous 4 days)
• •11. 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.)
• •12. 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
• •13. Concomitant treatments with anti-emetics
• •14. 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)
• •15. Alcohol or drug abuse as defined by diagnostic and statistical manual of mental disorders (DSM-IV)
• •16. Pregnancy and lactation
• •17. Gastrointestinal ulcers
• •18. Pathologically increased bleeding tendency
• •19. Glucose-6-phosphate dehydrogenase deficiency
• •20. Hypersensitivity to paracetamol, caffeine, ASA, salicylates, and other anti-inflammatory/anti-rheumatic agents or other allergenic substances that are relevant to the clinical trial
• •21. Bronchial asthma
• •22. Concomitant treatment with anticoagulants (e.g. coumarin derivates, heparin)
• •23. Clinically relevant chronic or recurrent gastrointestinal symptoms
• •24. Clinically relevant liver disorders
• •25. Clinically relevant pre-existing renal damage
• •26. Gilbert's syndrome
• •27. Not successfully treated hyperthyroidism
• •28. Simultaneous participation in another clinical trial
• •29. Participation in another clinical trial within 4 weeks of entering this study