Clinical Trial: Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Patients With Symptomatic Non-Ero

Brief Summary: The purpose of this study is to determine the efficacy 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).

Detailed Summary:

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 11 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.


Sponsor: Takeda

Current Primary Outcome: Percentage of days without daytime or nighttime heartburn [ Time Frame: Up to 4 weeks ]

The presence of daytime and nighttime heartburn symptoms will be recorded by study participants in a daily eDiary.


Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of days without nighttime heartburn [ Time Frame: Up to 4 weeks ]

The presence of nighttime heartburn symptoms will be recorded by study participants in a daily eDiary


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: August 17, 2016
Date Started: December 2016
Date Completion: March 2018
Last Updated: January 26, 2017
Last Verified: January 2017