Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy

A Phase 3b Multicenter, Single-Blind Trial to Evaluate the Efficacy of Dexlansoprazole MR 30 mg in Maintaining Control of Gastroesophageal Reflux Disease Symptoms in Subjects on Prior Twice Daily Proton Pump Inhibitor Therapy

The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.

Gastroesophageal reflux disease is recognized as a common and persistent medical problem in the US adult population. Gastroesophageal reflux disease comprises a spectrum of acid-related disorders including symptomatic nonerosive gastroesophageal reflux disease and erosive esophagitis. It affects men and women in nearly equal proportions, and the severity and intensity of heartburn symptoms may be similar in both types of patients.

Dexlansoprazole modified release is a dual delayed release formulation that consists of two types of granules contained in a single capsule. This dual delayed release formulation is designed to extend the duration of drug exposure and maintain pharmacologically active levels over a longer time period.

The purpose of this study is to demonstrate that participants with gastroesophageal reflux disease whose symptoms are well-controlled on twice daily proton pump inhibitors, remain well-controlled when switched to dexlansoprazole MR.

Inclusion Criteria:

1. Prior to any study-specific procedures being performed, the participant voluntarily signs an Investigational Review Board-approved informed consent form (ICF) and any privacy statement/authorization form required (eg, The Health Insurance Portability and Accountability Act (HIPAA) authorization)
2. Has a history of gastroesophageal reflux disease symptom, including heartburn, prior to therapy, who are currently being treated with twice daily proton pump inhibitors, excluding Dexilant (dexlansoprazole).
3. Taking a stable dose of any twice daily proton pump inhibitors for less than or equal to 1 year and greater than 8 weeks prior to Screening.
4. Participant is well-controlled on their current twice daily proton pump inhibitors.
5. Females cannot be nursing and must have a negative urine pregnancy test at Day -1 or be of non-childbearing potential. If females are of child bearing potential, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test during Screening and on an acceptable form of contraception, or have had bilateral tubal ligation if performed a minimum of 90 days prior to Day 1.

Exclusion Criteria:

1. Has a history of co-existing diseases affecting the esophagus, history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.

2. Has active gastric or duodenal ulcers during the 30 days prior to Screening.

3. Has acute upper gastrointestinal hemorrhage during the 30 days prior to Screening.

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

5. Has known hypersensitivity to any proton pump inhibitor or any component of dexlansoprazole MR.

6. Use of any Histamine type-2 receptor antagonist or antacids during Screening or anticipated use during the study treatment period.

7. Use of the following medications 7 days prior to Screening or anticipated use during the study:

   • Sucralfate.
   • Misoprostol.
   • Systemic corticosteroids.
   • Prokinetics (to include metoclopramide, cisapride, tegaserod).
   • Bisphosphonates during the 6 months prior to Screening or anticipated use during the study.
   • Chronic use (> 12 doses per month) of nonsteroidal anti-inflammatory drugs
   • Drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with central nervous system effects that could mask perception of symptoms.
   • Any investigational drug(s) within 30 days of Screening.

8. Has received blood products within the 3 months prior to Screening.

9. History of alcohol abuse or illegal drug use or drug addiction in the 12 months prior to Screening.

10. Evidence of uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.

11. Atypical manifestations of gastroesophageal reflux disease.

12. Has abnormal screening laboratory values that suggest a clinically significant underlying disease or condition.

13. Cancer within 5 years prior to Screening.

14. Is known to have acquired immunodeficiency syndrome.

15. Has any condition that is likely to require inpatient surgery during the course of the study.

16. Surgery of the acute upper gastrointestinal tract, including bariatric.

17. Is in the opinion of the investigator unable to comply with the requirements of the study or are unsuitable for any reason.