Who is sponsoring NCT00255151?

NCT00255151 is sponsored by Takeda.

What condition does NCT00255151 study?

NCT00255151 studies Esophagitis, Reflux, Esophagitis, Peptic.

What drugs are being tested in NCT00255151?

Interventions: Dexlansoprazole MR, Dexlansoprazole MR, Placebo.

What is the status of NCT00255151?

NCT00255151 is currently COMPLETED.

Last reviewed 2012-02-01 · How we verify

A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis

NCT00255151 Phase 3 COMPLETED Results posted

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).

Details

Lead sponsor	Takeda
Phase	Phase 3
Status	COMPLETED
Enrolment	451
Start date	2006-01
Completion	2006-11

Conditions

Esophagitis, Reflux
Esophagitis, Peptic

Interventions

Dexlansoprazole MR
Dexlansoprazole MR
Placebo

Primary outcomes

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. — 6 months
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method — 6 months
Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.

Countries

United States