A Double-blind, Randomized, Placebo-controlled Clinical Trial to Confirm the Rationale of the ASA + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients

NCT02183688 Phase 3 COMPLETED

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

Details

Lead sponsor	Boehringer Ingelheim
Phase	Phase 3
Status	COMPLETED
Enrolment	1889
Start date	1998-09

Conditions

• Migraine Disorders

Interventions

• Low dose ASA
• High dose ASA
• Low dose paracetamol
• High dose paracetamol
• Caffeine
• Placebo

Primary outcomes

• Calculated time to 50% pain relief, based on the pain intensity evaluated on a visual analogue scale (VAS) — 30 min., 1, 2, 3 and 4 hours after administration of the study medication