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).
This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis. Because the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (this study, NCT00255164) and T-EE04-087 (NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
451
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.
Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Time frame: 6 months
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
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.
Time frame: 6 months
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.
Time frame: 6 months
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked
Time frame: 6 months
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time frame: 6 months
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
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The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time frame: 6 months