Conditions: Pain
Keywords: Extended-release ibuprofen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 196
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, \[roller compaction\] and \[wet granulation\] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.

Detailed description:

Arms:
arm 1: 1 x 600 mg ibuprofen IR/ER-roller compaction caplet arm 2: 1 x 600 mg ibuprofen IR/ER-Wet granulation caplet arm 3: 1x 220 mg naproxen sodium (Aleve caplet) arm 4: 1 x placebo caplet

Interventions: intervention 1: ibuprofen intervention 2: ibuprofen intervention 3: naproxen intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: