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Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

Gastroesophageal Reflux Disease Clinical Trial

Official title:
A Phase 3 Double-blind Study to Evaluate the Efficacy and Safety of Dexlansoprazole (30 mg QD) Compared to Placebo on Heartburn Relief in Subjects With Symptomatic Nonerosive Gastroesophageal Reflux Disease (GERD)

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of dexlansoprazole compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).

Clinical Trial Description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat heartburn in people who have non-erosive gastroesophageal reflux disease (GERD). This study will look at heartburn relief in people who take dexlansoprazole.

The study will enroll approximately 200 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 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, and will be asked to record any time they have heartburn symptoms in a diary.

This multi-center trial will be conducted in China. The overall time to participate in this study is up to 7 weeks. Participants will make 4 visits to the clinic, and will be contacted by telephone 5 to 10 days after the last dose of study drug for a follow-up assessment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02873689
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date December 27, 2016
Completion date April 19, 2018
View Details
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