Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease; GERD; Heartburn
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn
Intervention: nizatidine (axid); nizatidine (axid); placebo
Intervention description: nizatidine (axid); nizatidine (axid); placebo
Intervention MeSH terms: Nizatidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 30 Days
Maximum age: 1 Year
Healthy volunteers: No
Keywords: gastroesophageal reflux disease; GERD; heartburn

Summary:

      The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid
      Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in
      infants age 30 days up to 1 year.
    

Eligibility criteria:

        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.