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

 1. Female or male out-patients aged between 18 and 65 years

 2. Diagnosis: Headache

 1. Tension type headache according to international headache society (IHS) Headache
 Classification 2.1 (2.1.1 and 2.1.2) and/or

 2. Migraine according to IHS Headache Classification 1.1, 1.2.1 or

 3. Either a) or b), but cannot be distinctly classified

 3. The patient normally treats his/her headache successfully with non-prescription
 analgesics

 4. He/She has been suffering from headache for 12 months at least

 5. The headache first occurred before the age of 50 years

 6. During the previous three months, the patient has suffered from headache twice a month
 at least

 7. Informed consent according to §§ 40, 41 of the german medicines act and Good Clinical
 Practice (GCP)

 8. The patient seems likely to comply

 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