A Phase 2 Study of Dexlansoprazole Delayed-Release Capsules to Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Pediatric Subjects Aged 1 to 11 Years

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
tested to treat children aged 1 to 11 years who have nonerosive gastroesophageal reflux
disease (GERD). This study will look at the effectiveness and side effects of three different
doses of dexlansoprazole in children with GERD.

The study will enroll approximately 80 patients. Participants weighing ≤30 kg will be
randomly assigned (by chance, like flipping a coin) to receive dexlansoprazole 15 or 30 mg,
and participants who weigh >30 kg will be randomized to receive dexlansoprazole 30 or 60 mg.

All participants will be asked to take one capsule at the same time each day throughout the
study. Parents/caregivers for participants ages 1 to 8 and participants ages 9 to 11 will be
asked to record any time they have heartburn symptoms in an electronic diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this
study is up to 16 weeks, which includes up to 4 weeks to screen for the study. Participants
will make multiple visits to the clinic, plus a final phone call 5 to 10 days after last dose
of study drug for a follow-up assessment.

Inclusion Criteria:

1. In the opinion of the investigator, the participant (as age appropriate) and/or
parent(s)/legal guardian is capable of understanding and complying with protocol
requirements.

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

3. Has a medical history of symptoms of gastroesophageal reflux disease (GERD) for at
least 3 months prior to Screening.

4. Has a medical history of at least 1 failed attempted withdrawal of prior proton pump
inhibitor (PPI)/acid suppressive therapy and a return of symptoms upon withdrawal.

5. Has met the electronic diary (eDiary) qualification criteria as assessed by the
Pediatric Gastroesophageal Reflux Disease Symptom Daily Diaries (PGSDD), defined as
hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive
days during the Screening Period.

6. Has either (1) a positive endoscopy with both a Hetzel-Dent (HD) Grade 1 and a
Histologic Features of Reflux Esophagitis (HFRE) Scale Grade <2, OR (2) an endoscopy
with HD Grade 0 and a documented pH-metry suggestive of acid-related disease. The
pH-metry should be performed during Screening or within 6 months of signing informed
consent and assent (as applicable) for GERD symptoms. An endoscopy performed within 1
week prior to signing informed consent and assent (as applicable), is an acceptable
replacement for the screening endoscopy if GERD is documented by the HD classification
scale criterion previously described, protocol-required biopsies were collected and
endoscopic pictures were obtained.

7. Is male or female and age 1 to 11 years inclusive at Screening.

Exclusion Criteria:

1. Has evidence of cardiovascular, pulmonary, central nervous system, hepatic,
hematopoietic, renal, or metabolic disorder, severe allergy, asthma, or allergic skin
rash that suggests any uncontrolled, clinically significant 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. Has a coexisting 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. Has any findings 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.

4. Has a history of hypersensitivity or allergies to dexlansoprazole, any component of
dexlansoprazole or any PPI (including lansoprazole, omeprazole, rabeprazole,
pantoprazole, or esomeprazole) or antacids.

5. Is required to take excluded medications or it is anticipated that the participant
will require treatment with at least 1 of the disallowed concomitant medications
during the study evaluation period.

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

7. Has known history of Barrett's esophagus with dysplastic changes in the esophagus.

8. Has history of eosinophilic esophagitis (EoE) endoscopic or histologic findings
suggestive of EoE (>15 eosinophils per high-powered field [HPF])

9. Has history of celiac disease, tests positive for tissue transglutaminase (tTG)
antibody or confirmed disease by histology.

10. Has history of inflammatory bowel disease, or irritable bowel syndrome.

11. Has active gastric or duodenal ulcers within 4 weeks prior to Day -1.

12. 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.

13. A female participant who has reached menarche.

14. Is known to be positive for the human immunodeficiency virus (HIV).

15. Has current or historical evidence of Zollinger-Ellison syndrome or other
hypersecretory condition.

16. 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.

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

18. Has donated or lost >10% of the total blood volume, undergone plasmapheresis, or has
had a transfusion of any blood product within 90 days prior to the first dose of study
drug.

19. Has a known history of alcohol abuse or illegal drug use within the past 12 months
prior to the first dose of study drug.

20. Has any screening 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.

21. 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 (as applicable) 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.

22. The participant, in the opinion of the investigator, is unlikely to comply with the
protocol or is unsuitable for any other reason.

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