Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

Phase 3 Completed 200 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache.

Timeline

Start: 2010-03
Primary completion: 2010-10
Completion: 2010-10

Publications

Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ibuprofen	Small molecule	400 mg	—
Comparator	Ibuprofen	Small molecule	512 mg	—

Indications

No indication recorded.