Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn
Brief Summary: This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn


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:

* Symptoms suggestive of GERD, with heartburn as their predominant symptom (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck), for longer than 6 months.
* Heartburn occurring for 4 days or more during the last 7 days prior to endoscopy. Or, if PPI treatment has been started within the last 7 days prior to endoscopy, then heartburn occurring for 4 days or more during the last 7 days prior to start of PPI treatment
* Male or female, at least 18 years of age (for Austria, at least 19 years of age)
* Have given written informed consent
* Ability to read and write (literate)
* 7 symptom free (from heartburn) days in the last week prior to randomisation (day of visit not included)

Exclusion Criteria:

* Documented esophageal mucosal break
* History of esophageal, gastric or duodenal surgery, except closure and oversewing of an ulcer
* Chronic or recurrent abdominal pain associated with a chronic or recurrent bowel disturbance and/or bloating, that in the opinion of the investigator is likely to be due to irritable bowel syndrome or two or more of the following criteria:

  * Symptoms relieved by defecation
  * Symptoms associated with change in frequency of stools
  * Symptoms associated with change in form of stools
* Any significant "alarm symptoms" such as unintentional weight loss, haematemesis melaena, jaundice or any other sign indicating serious or malignant disease.
* Subjects with current or historical evidence of the following diseases/conditions

  * Zollinger Ellison syndrome
  * Primary esophageal motility disorder(s) i.e. achalasia, scleroderma, esophageal spasm
  * Complications of GERD such as esophageal stricture, ulcer and/or macroscopic Barrett's metaplasia (longer than 3 centimetres) or significant dysplastic changes in the esophagus
  * Evidence of upper gastrointestinal malignancy at the screening endoscopy
  * Gastric and/or duodenal ulcers within the last 2 years
  * Malabsorption
  * Malignancy, or significant cardiovascular, pulmonary, renal, pancreatic or liver disease as judged by the investigator
  * Unstable diabetes mellitus. Stable diabetes controlled on diet, oral agents or insulin is acceptable
  * Cerebrovascular disease, such as cerebral ischemia, infarction, haemorrhage or embolus
* Subjects using a PPI for more than 10 days in the last 28 days, prior to endoscopy
* Use of PPIs for more than 5 days in the last 7 days prior to endoscopy
* Subjects using daily H2-receptor antagonist, prokinetics recommended in the treatment of reflux symptoms or sucralfate during the 2 weeks prior to endoscopy and between the endoscopy and visit 1 and throughout the study
* Need for continuous concurrent therapy with

  * NSAIDs (including selective COX II antagonists, salicylates (unless\<165 mg daily for cardiovascular prophylaxis)
  * anticholinergics
  * prostaglandin analogues
  * phenytoin
  * ketoconazole
  * itraconazole
  * warfarin and other vitamin K antagonists
* Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator (for Austria: Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to entry and then at monthly basis. For South-Africa and Spain:

Women of child-bearing potential may only be included when their pregnancy status is assessed by the investigator prior to endoscopy)

* Use of any other investigational compound 28 days prior to start and during the study
* Requirement of an interpreter (illiterate)
* Alcohol and/or drug abuse or any condition associated with poor compliance, including expected non-co-operation, as judged by the investigator
* Previous participation in this study
* Contra-indications to study drugs, e.g. known or suspected allergy to esomeprazole and any other constituents of the formulation. Known hypersensitivity to substituted benzimidazole
C: 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
D: Inclusion Criteria:

* patients between the ages of 15 and 80 years
* with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach,
* who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy are recruited.

Exclusion Criteria:

1. coexistence of peptic ulcer or gastrointestinal malignancies,
2. pregnancy,
3. coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia),
4. previous gastric surgery,
5. allergy to esomeprazole,
6. symptom score of a validated questionnaire (Chinese GERDQ) less than 12, and
7. equivocal endoscopic diagnosis of Los Angeles Grade A and B erosive esophagitis.

Answer: C