Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)

Inclusion Criteria:

• Male or female outpatients age 30 days up to 1 year at Visit 1.

• Subjects must have a documented medical diagnosis of gastroesophageal reflux disease (GERD), confirmed by either endoscopy or pH monitoring, or by evaluation of baselinesymptoms.

• Subjects must be greater than the 3rd percentile of weight and height for their age.

• Parents/guardians are competent and willing to provide consent and sign and date theinstitutional review board (IRB) approved consent form.

• Parents/guardians are willing to adhere to study requirements, including applying theconservative GERD management methods.

• Conservative GERD management methods have failed to adequately control GERD symptomsby Visit 2.

• Parent/guardian and infant live in the same household.

• Qualifying caregiver questionnaire score at Visits 1 & 2.

Exclusion Criteria:

• Any known esophageal disease or disorder, other than reflux esophagitis.

• Any active gastroduodenal ulceration, or clinical or endoscopic evidence of activegastrointestinal bleeding.

• Any prior esophageal or gastric surgery.

• Concurrent serious systemic disorders, including chronic respiratory disease, chronicneurologic disease, chronic renal disease, chronic liver disease.

• Subjects with clinically significant abnormal laboratory findings at screening.

• Premature infants < 37 weeks gestation at birth.

• Infants with prior neonatal intensive care unit admission for any reason.

• Hematemesis or apparent life-threatening events (ALTE).

• Concurrent treatment with any chronic medication except by permission of the studysponsor.

• Treatment with a histamine 2 receptor antagonist (H2RA), antacid, sucralfate,prostaglandin, or motility agent within 3 days before Visit 1; treatment with a protonpump inhibitor within 7 days before Visit 1.

• Requirement or likely requirement for a medical procedure or surgery during the study.

• Known hypersensitivity to an H2RA including nizatidine.

• Receipt of any investigational agent within the previous 30 days before randomization.

• Poor medical or psychiatric risks for therapy with an investigational drug, in theopinion of the investigator.

• Any condition in parent/guardian associated with poor subject compliance e.g.,substance abuse); inability of parent/guardian to return for scheduled visits withtheir child.