Skip to main content
. 2014 Dec 11;2014(12):CD009281. doi: 10.1002/14651858.CD009281.pub3

NCT02183688.

Methods Randomised, double‐blind, placebo‐controlled, parallel‐group study
Participants Migraine or tension‐type headache (IHS). History ≥ 1 year, ≥ 2 episodes per month in previous 3 months, usually treated successfully with non‐prescription analgesics
N = 1889
Age 18 to 65 years
M and F
Interventions Low dose aspirin + low dose paracetamol + caffeine
Low dose aspirin + low dose paracetamol
High dose aspirin
High dose paracetamol
Caffeine
Placebo
Outcomes 50% pain relief at 0.5, 1, 2, 3, and 4 h
%max SPID
Impairment of daily activities (4‐point scale)
Patient global assessment of efficacy (4‐point scale)
Adverse events
Notes Completed; estimated final collection date for primary outcome January 2003
Sponsor: Boehringer Ingelheim

F: female; IHS: International Headache Society; M: male; N: number of participants in study; SPID: weighted sum of pain intensity difference; SPRID: weighted sum of pain relief and pain intensity difference