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Clinical Trial Summary

This is a study to assess the efficacy and safety of 8 weeks of treatment with Dexlansoprazole modified release (MR)(60 mg daily and 90 mg daily) compared to Lansoprazole (30 mg daily) in healing subjects with endoscopically proven erosive esophagitis.


Clinical Trial Description

This is a Phase 3, randomized, double-blind, multi-center, active-controlled, 3-arm study with an 8 week treatment period. This study will compare the efficacy of Dexlansoprazole MR (60 mg and 90 mg) with that of Lansoprazole (30 mg) when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate healing of erosive esophagitis and the effect of the therapy on relieving gastroesophageal reflux disease related symptoms. The study consists of two periods, a screening period (maximum 21 days) and a treatment period, which will last up to 8 weeks. ;


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 NCT00251719
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date December 2005
Completion date January 2007

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 NCT00255151 - Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain 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
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Recruiting NCT02049723 - Assessment of GERD Knowledge Level Among Patients With it in Korea N/A