Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
tested to treat adolescents who have erosive esophagitis and heartburn.

Inclusion Criteria:

1. In the opinion of the investigator, the participant and parent(s) or legal guardian
are capable of understanding and complying with protocol requirements.

2. Prior to any study-specific procedures being performed, the informed consent and the
assent form, according to local country requirements, must be signed and dated by
parent(s) or legal guardian and by the participant respectively.

3. The participant has a medical history of symptoms of GERD for at least 3 months prior
to Screening (signed informed consent form and assent, if applicable) as assessed by
the investigator.

4. The participant has met the electronic diary qualification criteria as assessed by
the electronic daily diary defined as follows: heartburn (burning or hurting in your
throat, chest, or stomach) on at least 3 of 7 days.(Note: if an endoscopy done within
1 week of signing informed consent and assent is used to confirm diagnosis of EE, the
subject does not need to meet this criterion).

5. The participant has endoscopic evidence of EE (LA Grade A-D) based on the screening
endoscopy.

6. The participant is male or female and aged 12 to 17 years, inclusive.

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 and assent throughout the duration of the study and for 30 days after last
dose of study medication.

8. A female participant of childbearing potential who is or may become sexually active
agrees to routinely use adequate contraception from the time of signing the informed
consent and assent until 30 days after the last dose of study medication.

Exclusion Criteria:

1. Participant 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. The participant has a co-existing disease affecting the esophagus (eg, 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.

3. The participant has known history of Barrett's with dysplastic changes in the
esophagus.

4. The participant has a known history of eosinophilic esophagitis (EoE) or endoscopic
findings suggestive of EoE.

5. The participant has a history of celiac disease or participant tests positive for tTG
antibody.

6. The participant has active gastric or duodenal ulcers within 4 weeks prior to Day -1.

7. Participant 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.

8. Participant has taken any PPI within 1 week (7 days) prior to the Screening Visit.

9. Participant tests positive for H. pylori.

10. The participant has a history of hypersensitivity or allergies to dexlansoprazole or
any component of dexlansoprazole or any PPI (including lansoprazole, omeprazole,
rabeprazole, pantoprazole, or esomeprazole) or antacid containing Mg(OH)2 and/or
Al(OH)3 or simethicone.

11. The participant 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 7.3.

12. The participant has a history of malignant disease (except basal cell carcinoma)
within 5 years prior to Screening.

13. The participant has a condition that may require inpatient surgery during the course
of the study.

14. The participant 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.

15. The participant is known to be human immunodeficiency virus (HIV) positive.

16. The participant has current or clinical history of Zollinger-Ellison syndrome or
other hypersecretory condition.

17. The participant 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.

18. The participant had an acute upper gastrointestinal hemorrhage within 4 weeks prior
to endoscopy.

19. The participant 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.

20. The participant has a known history of alcohol abuse or illegal drug use within the
past 12 months prior to the first dose of study drug.

21. The participant has any Screening Visit 1 abnormal laboratory value that suggests a
clinically significant underlying disease or condition that may prevent the
participant from entering the study; or the participant has: creatinine >1.5 mg/dL,
alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times the
upper limit of normal (×ULN), or total bilirubin >2.0 mg/dL with AST/ALT elevated
above the limits of normal values.

22. 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.

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

24. The participant, participant's Parent(s) or Legal Guardian 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.

25. The participant or participant's Parent(s) or Legal Guardian, in the opinion of the
investigator, is unlikely to comply with the protocol requirements or is unsuitable
for any other reason.

26. The participant has participated in another clinical study and/or has received any
investigational compound within 30 days prior to Screening.