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Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation

NCT02162758 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-05-11

Study results available
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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).

Conditions

  • Barrett's Esophagus

Interventions

DRUG

Dexlansoprazole

Dexlansoprazole delayed-release capsules

DRUG

Dexlansoprazole Placebo

Dexlansoprazole placebo-matching capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02162758 on ClinicalTrials.gov