Clinical Trial: Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3 Study to Evaluate the Safety and Efficacy of TAK-390MR (30 mg QD and 60 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis.

Brief Summary: The purpose of this study is to assess the ability of once-daily (QD) treatment with dexlansoprazole modified release (MR) 30 mg and 60 mg or placebo in maintaining healing of erosive esophagitis (EE).

Detailed Summary: This is a Phase 3, randomized, double-blind, multicenter, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily dexlansoprazole MR (30 mg and 60 mg) with that of placebo, in maintaining healing of EE.
Sponsor: Takeda

Current Primary Outcome:

  • Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis. [ Time Frame: 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 [ Time Frame: 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.


Original Primary Outcome: - Percentage of subjects who maintained complete healing of erosive esophagitis over 6 months as assessed by endoscopy.

Current Secondary Outcome:

  • Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median. [ Time Frame: 6 months ]
    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 ]
    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 ]
    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 ]
    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.


Original Secondary Outcome:

  • Mean percentage of days without daytime or nighttime heartburn over 6 months as assessed by daily electronic diary.
  • Mean percentage of days without nighttime heartburn over 6 months as assessed by daily electronic diary.


Information By: Takeda

Dates:
Date Received: May 2, 2006
Date Started: May 2006
Date Completion:
Last Updated: February 1, 2012
Last Verified: February 2012