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Clinical Trial 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).


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00255151
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date January 2006
Completion date November 2006

See also
  Status Clinical Trial Phase
Completed NCT02463643 - To Evaluate Efficacy and Safety of Z-215 in Erosive Esophagitis Phase 2
Completed NCT00321737 - Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis Phase 3
Completed NCT00255164 - Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis Phase 3
Suspended NCT00282555 - Efficiency Study of S-Tenatoprazole-Na to Treat Erosive or Ulcerative Esophagitis Phase 2
Completed NCT00251693 - Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis Phase 3
Completed NCT00251719 - Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis Phase 3
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