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

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 Radiofrequency Ablation
(RFA). The study will enroll approximately 150 patients. 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.

Inclusion Criteria:

1. Is male or female and aged 18 to 80 years, inclusive.

2. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.

3. The participant or, when applicable, the participant's legally acceptable
representative signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedures.

4. Has a history of initial complete eradication of intestinal metaplasia (CEIM)
following radiofrequency ablation (RFA) for Barrett's esophagus with high-grade
dysplasia within the past 3 years.

5. Had attained CEIM within 12 months of receiving his or her first RFA treatment.

6. Has endoscopic and histologic confirmed evidence of CEIM prior to randomization.

7. A male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from signing of informed
consent throughout the duration of the study and for 12 weeks after last dose.

8. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from
signing of informed consent throughout the duration of the study.

Exclusion Criteria:

- 1. Has evidence of cardiovascular, pulmonary, central nervous system, hepatic,
hematopoietic, renal, metabolic, endocrine or gastrointestinal disease, or serious
allergy, asthma, or allergic skin rash that suggests clinically significant,
uncontrolled underlying disease or condition (other than the disease being studied),
which may impact the ability of the participant to participate or potentially
confound the study results.

2. Had previous ablative therapy with a modality other than RFA for Barrett's
esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma
coagulation, or laser treatment) with the exception of up to 3 treatments of
thermal/coagulation therapy for focal residual disease following otherwise successful
RFA therapy.

3. Has a co-existing disease affecting the esophagus (eg, erosive esophagitis,
esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture),
history of radiation therapy or cryotherapy to the esophagus, caustic or
physiochemical trauma such as sclerotherapy to the esophagus.

4. Has a known history of eosinophilic esophagitis or endoscopic findings suggestive
of eosinophilic esophagitis.

5. Has active gastric or duodenal ulcers within 4 weeks prior to Day -1. 6. Has any
finding in his/her medical history, physical examination, or safety clinical
laboratory tests giving reasonable suspicion of underlying disease that might
interfere with the conduct of the trial.

7. Has a history of hypersensitivity or allergies to dexlansoprazole or any component
of dexlansoprazole or any proton pump inhibitor (PPI) (including lansoprazole,
omeprazole, rabeprazole, pantoprazole, or esomeprazole) or antacid.

8. Is required to take excluded medications or it is anticipated that the participant
will require treatment with at least one of the disallowed concomitant medications
during the study evaluation period as specified in the Excluded Medications and
Treatments Section..

9. Has a history of malignant disease (except basal cell carcinoma) within 5 years
prior to Screening.

10. Has a condition that may require inpatient surgery during the course of the
study.

11. Requires dilatation of esophageal strictures and/or strictures preventing passage
of the endoscope during the Screening endoscopy. Schatzki's ring (a ring of mucosal
tissue near the lower esophageal sphincter) is acceptable.

12. Is known to have acquired immunodeficiency syndrome. 13. Has current or clinical
history of Zollinger-Ellison syndrome or other hypersecretory condition.

14. Has a history of gastric, duodenal or esophageal surgery except simple oversew of
an ulcer. A history of gastric tube and/or percutaneous endoscopic gastrostomy (PEG)
placement is allowed.

15. Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy.

16. Has donated or lost ≥300 mL blood volume, undergone plasmapheresis, or has had a
transfusion of any blood product within 90 days prior to the first dose of study
drug.

17. Has a known history of alcohol abuse or illegal drug use within the past 12
months prior to the first dose of study drug, or is unwilling to agree to abstain
from alcohol or illegal drug use throughout the study.

18. If female, the participant is pregnant or lactating or intending to become
pregnant before, during or within 30 days after last dose of study medication; or
intending to donate ova during such time period.

19. If male, the participant intends to donate sperm during the course of this study
or within 30 days after last dose of study drug.

20. Is an immediate family member, study site employee, or is in a dependent
relationship with a study site employee who is involved in the conduct of this study
or may consent and assent under duress. Students of the institution/research facility
who are under the supervision of, or in a subordinate role to, the investigator are
also ineligible.

21. In the opinion of the investigator, is unlikely to comply with the protocol
requirements or is unsuitable for any other reason.

22. Has been previously randomized in this study and received at least one dose of
double blind study drug treatment.

23. Has received any investigational compound within 30 days prior to Screening.