Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis

Summary

The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).

Timeline

Start

2006-01

Primary completion

2006-11

Completion

2006-11

Outcome

Met primary endpoint

paper Dexlansoprazole MR 60 and 90 mg were superior to placebo for maintaining healing (P < 0.0025). PMID 19681809 ↗

registry Placebo QD vs Dexlansoprazole MR 60 mg QD; p <0.00001; Fisher Exact NCT00255151 ↗

registry Placebo QD vs Dexlansoprazole MR 90 mg QD; p <0.00001; Fisher Exact NCT00255151 ↗

Publications

• Results Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.

Drugs

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

Indications