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

Launched by BOEHRINGER INGELHEIM · Jul 7, 2014

Keywords

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Gender

ALL

Eligibility criteria

• 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