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

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.