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 baseline symptoms.
• 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 the institutional review board (IRB) approved consent form.
• Parents/guardians are willing to adhere to study requirements, including applying the conservative GERD management methods.
• Conservative GERD management methods have failed to adequately control GERD symptoms by 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 active gastrointestinal bleeding.
• Any prior esophageal or gastric surgery.
• Concurrent serious systemic disorders, including chronic respiratory disease, chronic neurologic 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 study sponsor.
• Treatment with a histamine 2 receptor antagonist (H2RA), antacid, sucralfate, prostaglandin, or motility agent within 3 days before Visit 1; treatment with a proton pump 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 the opinion 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 with their child.