NCT01929031.
Methods | Randomised, double‐blind, placebo‐controlled, parallel‐group study Single and multiple dose phases |
Participants | Third molar extraction (3 to 4 molars, ≥ 2 mandibular) N = 561 Age 18 to 55 years M and F Pain intensity moderate (≥ 5/10) |
Interventions | Ibuprofen 400 mg + caffeine 100 mg Ibuprofen 400 mg Caffeine 100 mg Placebo |
Outcomes | SPRID 0 to 2 h Time to rescue medication |
Notes | Completed; estimated final collection date for primary outcome March 2014 Sponsor: Boehringer Ingelheim |