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

Inclusion Criteria:

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

2. Diagnosis: Headache

3. Tension type headache according to international headache society (IHS) HeadacheClassification 2.1 (2.1.1 and 2.1.2) and/or

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

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

6. The patient normally treats his/her headache successfully with non-prescriptionanalgesics

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

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

9. During the previous three months, the patient has suffered from headache twice a monthat least

10. Informed consent according to §§ 40, 41 of the german medicines act and Good ClinicalPractice (GCP)

11. The patient seems likely to comply

Exclusion Criteria:

1. The patient treats his/her headache with prescription-only analgesics or migraineremedies

2. The patient requires higher single doses of non-prescription analgesics to treathis/her headache than indicated in the patient information leaflet (e.g. more than 2tablets of Thomapyrin tablets)

3. The patient normally treats his/her headache with non-prescription analgesics ineffervescent tablet form

4. The patient normally takes his/her non-prescription analgesics immediately at theonset 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 thatmay 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 thatinfluence headache symptoms, e.g. Propanolol, Metoprolol, Flunarizine, Cyclandelate, Valproic acid, Serotoninantagonists (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 orother 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 mentaldisorders (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 otheranti-inflammatory/anti-rheumatic agents or other allergenic substances that arerelevant 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