The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).
This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. sites. The study consists of two periods; a Screening Period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks. Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (NCT00241745) and T-GD04-083 (this posting, NCT00251758), were combined and analyzed as a single larger study, referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
908
Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.
Dexlansoprazole MR 90 mg, capsules, orally, once daily for 4 weeks.
Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Time frame: 4 weeks
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Time frame: 4 weeks
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time frame: 4 weeks
Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time frame: 4 weeks
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