This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).
The drug being tested in this study is called dexlansoprazole. The purpose of this study is to evaluate the effect of 12 months of treatment with dexlansoprazole 60 mg QD or dexlansoprazole 60 mg BID on the recurrence of IM in participants who have achieved complete eradication of intestinal metaplasia (CEIM) and dysplasia (CED) with RFA. The study will enroll approximately 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Dexlansoprazole 60 mg once a day and placebo (this is a capsule that looks like the study drug but has no active ingredient) once a day * Dexlansoprazole 60 mg twice a day. All participants will be asked to take one capsule twice a day at the same time each day throughout the study. This randomized, double-blind, multi-center, parallel group trial will be conducted in North America. The overall time to participate in this study is up to 13 months. Participants will make 5 visits to the clinic, and will undergo a safety follow-up assessment 30 days after the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
Dexlansoprazole delayed-release capsules
Dexlansoprazole placebo-matching capsules
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Chapel Hill, North Carolina, United States
Unnamed facility
Chapel Hill, North Carolina, United States
Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)
Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.
Time frame: Month 12
Percentage of Participants With Recurrence of IM With Dysplasia
Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.
Time frame: Month 12
Percentage of Participants With Erosive Esophagitis (EE)
The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference.
Time frame: Baseline up to Month 12
Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score
The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating to do daily activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score is 50 (incapacitated in all questions).
Time frame: Baseline and Month 12
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Unnamed facility
Knoxville, Tennessee, United States
Unnamed facility
Knoxville, Tennessee, United States