Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
Brief Summary: 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.


Options:
A: 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.
B: Inclusion Criteria:

* Males and non-pregnant ,non-lactating females 18 years or older
* Experience heartburn at least 2 days a week
* Having heartburn that has responded to heartburn medication
* Must discontinue any current heartburn medications

Exclusion Criteria:

* Having a history of erosive esophagitis verified by endoscopy
* Having a history of GERD which was diagnosed by a physician
* Inability to take study medication or complete the study and all study procedures
* Subjects that have required more than one 14-day course of PPI treatment within the past 4 months
C: Inclusion Criteria:

* Subjects must have successfully completed either T-GD04-082 (NCT00251745) or T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with or without erosive esophagitis.

Exclusion Criteria:

* Any condition that may require inpatient surgery during the course of the study.
* Use of prescription or non-prescription proton pump inhibitors, histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.
* Use of antacids \[except for study supplied Gelusil®\].
* Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.
* Evidence of uncontrolled systemic disease.
* Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others, any component of dexlansoprazole MR, or Gelusil/antacid.
* Need to take blood thinners.
* Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.
* Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.
* Has other esophageal disease including Barrett's esophagus or strictures requiring dilation.
* Has had radiation or cryotherapy to the esophagus.
* Has active gastric or duodenal ulcers within 4 weeks of starting study drug.
* Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.
* History of alcohol abuse.
* Has acquired immunodeficiency syndrome.
* Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.
* Received a blood product transfusion within 3 months of taking the first dose of study drug.
* Has previously participated in another dexlansoprazole MR long-term treatment clinical trial.
D: Inclusion Criteria:

* Males and non-pregnant ,non-lactating females 18 years or older
* Experience heartburn at least 2 days a week
* Having heartburn that has responded to heartburn medication
* Must discontinue any current heartburn medications

Exclusion Criteria:

* Having a history of erosive esophagitis verified by endoscopy
* Having a history of GERD which was diagnosed by a physician
* Inability to take study medication or complete the study and all study procedures
* Subjects that have required more than one 14-day course of PPI treatment within the past 4 months

Answer: A