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

NCT ID: NCT02183688

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1889 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-09-30

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, and placebo administered orally to headache patients for two headache episodes

Conditions

Migraine Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ASA + paracetamol + caffeine

Group Type: EXPERIMENTAL

Low dose ASA

Intervention Type: DRUG

Low dose paracetamol

Intervention Type: DRUG

Caffeine

Intervention Type: DRUG

ASA + paracetamol

Group Type: ACTIVE_COMPARATOR

Low dose ASA

Intervention Type: DRUG

Low dose paracetamol

Intervention Type: DRUG

ASA

Group Type: ACTIVE_COMPARATOR

High dose ASA

Intervention Type: DRUG

Paracetamol

Group Type: ACTIVE_COMPARATOR

High dose paracetamol

Intervention Type: DRUG

Caffeine

Group Type: ACTIVE_COMPARATOR

Caffeine

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Low dose ASA

Intervention Type: DRUG

High dose ASA

Intervention Type: DRUG

Low dose paracetamol

Intervention Type: DRUG

High dose paracetamol

Intervention Type: DRUG

Caffeine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

155.8

Identifier Type: -

Identifier Source: org_study_id