Conditions: Barrett's Esophagus
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 6
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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.

Arms:
arm 1: Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole 60 mg placebo-matching capsules, orally, once daily for up to 12 months. arm 2: Dexlansoprazole 60 mg, delayed-release capsules, orally, BID for up to 12 months.

Interventions: intervention 1: Dexlansoprazole intervention 2: Dexlansoprazole Placebo
Intervention descriptions: intervention 1: Dexlansoprazole delayed-release capsules intervention 2: Dexlansoprazole placebo-matching capsules

Protocol document: