Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn

Phase 3 Completed 908 enrolled Takeda

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).

Timeline

Start: 2005-12
Primary completion: 2006-05
Completion: 2006-05

Outcome

Met primary endpoint

registry MEDIAN Dexlansoprazole MR 60 mg QD: 45.7 (11.1 to 75.0) percentage of days NCT00251745 ↗

registry Placebo QD vs Dexlansoprazole MR 60 mg QD; p <0.00001; Wilcoxon (Mann-Whitney) NCT00251745 ↗

Publications

Results Peura DA, Metz DC, Dabholkar AH, Paris MM, Yu P, Atkinson SN. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: global clinical trial experience. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1010-21. doi: 10.1111/j.1365-2036.2009.04137.x. Epub 2009 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexlansoprazole	Other / unclassified	60 mg	Oral
Subject	Dexlansoprazole	Other / unclassified	90 mg	Oral