NCT02873702

Efficacy and Safety of Dexlansoprazole in Healing and Maintaining Healing of Erosive Esophagitis

A Phase 3 Study to Evaluate the Efficacy and Safety of Dexlansoprazole (60 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis, and Maintenance of Healing in Subjects With Healed Erosive Esophagitis With Dexlansoprazole (30 mg QD) and Placebo

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of dexlansoprazole compared to lansoprazole in healing erosive esophagitis (EE) in Chinese participants.

Detailed description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat people who have EE. This study will look at erosive esophageal healing in people who take dexlansoprazole. The study will enroll approximately 450 participants. Participants will be randomly assigned to one of the two treatment groups with 1:1 ratio-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * Dexlansoprazole 60 mg * Lansoprazole 30 mg After 8 weeks of treatment, participants will be evaluated to assess esophageal healing. If the EE is healed participants will be randomly assigned to one of two different treatment groups with 1:1 ratio: * Dexlansoprazole 30 mg * Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient. All participants will be asked to take one capsule at the same time each day throughout the study. This multi-center trial will be conducted in China. The overall time to participate in this study is up to 39 weeks. Participants will make 7 visits to the clinic, and will be contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment.

Conditions

• Erosive Esophagitis

Interventions

Type	Name	Description
DRUG	Dexlansoprazole	Dexlansoprazole delayed-release capsules.
DRUG	Lansoprazole	Lansoprazole capsules.
DRUG	Placebo	Dexlansoprazole placebo-matching capsules.

Timeline

• Start date: 2016-12-21
• Primary completion: 2017-10-16
• Completion: 2017-11-06
• First posted: 2016-08-19
• Last updated: 2019-02-22
• Results posted: 2019-02-22

Locations

25 sites across 1 country: China