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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
217
Dexlansoprazole delayed-release capsule
Dexlansoprazole placebo-matching capsules
Peking University First Hospital
Beijing, Beijing Municipality, China
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment
The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)\*100 percent (%).
Time frame: Up to Week 4
Percentage of Days Without Nighttime Heartburn During Treatment
The percentage of days without nighttime heartburn was = (the days that were heartburn-free during the treatment period) / (total number of days for which nighttime result was marked during treatment period)\*100%.
Time frame: Up to Week 4
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
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