Onset of analgesia with ibuprofen sodium in tension-type headache: a randomized trial.

ABSTRACT: BACKGROUND:Ibuprofen is known to be efficacious in the treatment of tension-type headache, the most common form of primary headache. A novel tablet formulation of ibuprofen sodium is more rapidly absorbed than standard ibuprofen. This study evaluated onset of analgesia and overall efficacy of ibuprofen sodium in episodic-type tension headache (ETTH) compared with standard ibuprofen and placebo. METHODS:This randomized, double-blind, single-center, parallel-group study included adults aged 18-65 years with ?4 moderately severe ETTHs per month for 6 months. Within 45 minutes of onset of at least moderately severe ETTH, subjects were randomized 2:2:1 to receive a single oral dose of ibuprofen sodium tablets (Advil® Film Coated; 2?×?256 mg [equivalent to 400 mg standard ibuprofen]), standard ibuprofen tablets (Motrin®; 2?×?200 mg), or placebo. The coprimary end points were time-weighted sum of pain relief rating and pain intensity difference scores over 3 hours (SPRID 0-3) and time to meaningful pain relief (MPR) assessed by double-stopwatch method. RESULTS:A total of 226 subjects were randomized to ibuprofen sodium (n?=?91), standard ibuprofen (n?=?89), and placebo (n?=?46). Demographics and baseline characteristics were comparable between treatment groups. Mean SPRID 0-3 scores were significantly superior (P?180 minutes, respectively). Time to MPR was numerically faster for ibuprofen sodium than standard ibuprofen. This difference was not statistically significant (P?=?.253) using the protocol-specified analysis but was (P?=?.022) in a post hoc analysis using the Gehan-Wilcoxon test, which assigns higher weights to earlier events. (The post hoc analysis was performed because Kaplan-Meier graphs and results for time to first perceptible relief favored ibuprofen sodium over standard ibuprofen at earlier time points.) There were no adverse events. CONCLUSIONS:This novel ibuprofen sodium tablet provided rapid, efficacious relief of ETTH and was well tolerated. TRIAL REGISTRATION:ClinicalTrials.gov NCT01362491.

SUBMITTER: Packman E 

PROVIDER: S-EPMC4728914 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature