Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

Phase 3 Completed 1083 enrolled Pfizer

NaSingle-groupOpen-labelTreatment

Summary

A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.

Timeline

Start: 2012-09-24
Primary completion: 2013-06-03
Completion: 2013-06-03

Outcome

Missed primary endpoint

paper CONCLUSION: Although the study did not meet the a priori primary efficacy outcome target, the majority of participants selected and used ibuprofen 600-mg IR/ER tablets correctly per the labeled instructions. PMID 27184785 ↗

Publications

Paluch E, Jayawardena S, Wilson B, Farnsworth S. Consumer self-selection, safety, and compliance with a novel over-the-counter ibuprofen 600-mg immediate-release and extended-release tablet. J Am Pharm Assoc (2003). 2016 Jul-Aug;56(4):397-404. doi: 10.1016/j.japh.2016.03.003. Epub 2016 May 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibuprofen	Small molecule	600 mg	Oral

Indications

No indication recorded.