Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Brief Summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Options:
A: Infants were eligible for the study if they were:

* 6-12 weeks postnatal age
* weighed more than 3 kg
* were after surgical repair for EA or CDH
* showed clinical GERD
* were to undergo the 48 hour pH measurements.

Infants were excluded if they were:

* allergic to omeprazole
* participated in other interventional trials
* used medications known to interact with omeprazole.
B: Inclusion Criteria:

* Body weight is greater than or equal to 30 kg.
* Females of childbearing potential who are sexually active must agree to use an acceptable form of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* Must have an estimated creatinine clearance greater than or equal to 80 mL/minute as determined from the Cockcroft-Gault formula.
* Participants who take prescription or non-prescription proton pump inhibitors, histamine receptor antagonists (except cimetidine), sucralfate, or antacids on a regular or as required basis must agree to discontinue usage throughout the study.
* Must have a history of gastroesophageal reflux disease symptoms, as documented by a physician, for at least 2 months prior to Screening or is currently symptomatic.
* Must be able to swallow study drug capsule or must be able to ingest study drug granules sprinkled on 1 tablespoon of applesauce.

Exclusion Criteria:

* Has evidence of current cardiovascular, central nervous system, hepatic, hematopoietic, renal, or metabolic dysfunction, serious allergy, asthma, or allergic skin rash.
* Has any finding in his/her medical history, physical examination, or safety clinical laboratory tests giving reasonable suspicion of a disease that might interfere with the conduct of the trial or that would contraindicate taking dexlansoprazole MR or a similar drug in the same class.
* Has a known hypersensitivity to any proton pump inhibitors or any component of the formulation of dexlansoprazole MR (see most current version of the Investigator Brochures).
* Has a history of malignant disease.
* Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody.
* Has a known history of infection with the human immunodeficiency virus.
* Has donated or lost greater than or equal to 300 mL blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug.
* Is required to take or intends to continue taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication.
* Has consumed grapefruit or grapefruit juice within 14 days prior to the first dose of study drug or is unwilling to agree to abstain from grapefruit or grapefruit juice while participating in the study.
* Has a history of alcohol abuse or illegal drug use or drug abuse in the past, or tests positive for alcohol or drugs of abuse at the initial Screening Visit or Day -1 or is unwilling to agree to abstain from alcohol and drugs throughout the study.
* Has used a product containing nicotine within 90 days prior to the first dose of study drug or has a positive cotinine screen at the initial Screening Visit or Day -1 or is unwilling to agree to abstain throughout the study.
* Has participated in a study of an investigational agent (including dosing or follow up) within 30 days prior to first dose of study drug.
* Has an initial Screening Visit or Day -1 laboratory value that the principal investigator considers to be clinically significant.
* Participant is determined to be a CYP2C19 isozyme poor metabolizer (ie, genotyped homozygous non-wild type).
* Is unlikely to comply with the protocol or is unsuitable for any other reason per the opinion of the investigator
C: Inclusion Criteria:

* Greater than 44 weeks beyond neonatal period but less than 12 months
* Presumptive diagnosis of GERD
* Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

* History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
* Clinically significant medical or surgical abnormalities
D: Inclusion Criteria:

* Patients' parents/guardians must provide written informed consent prior to the execution of any study-related procedures.
* Patients who are able to comprehend their involvement in a clinical study, including risks and benefits, (typically ≥6 years of age) must have assent documented by study personnel prior to any study-related procedures.
* Patients must be diagnosed with endoscopically proven GERD by the investigator during the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive esophagitis by endoscopy and are candidates for PPI therapy.

Exclusion Criteria:

* Patients who have used a proton pump inhibitor within 14 days prior to randomization, including over-the-counter omeprazole.
* Patients who have used any prescription or over-the-counter (OTC) treatment (other than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization.
* Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.

Answer: C