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

• Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  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.
  
  

• Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  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.
  
  
• Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  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
  
  
• Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  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.
  
  
• Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  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.
  
  

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 (NCT00255164) and T-EE04-087 (this study, 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.