Official Title: “A Double-Blind, Randomized, Parallel, Multicenter Study of Axid (Nizatidine) Oral Solution in the Treatment of Gastroesophageal Reflux Disease (GERD) Symptoms in Infants Age 30 Days-1 Year”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: nizatidine (axid)
  • nizatidine (axid)
• Drug: nizatidine (axid)
  • nizatidine (axid)
• Other: placebo
  • placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Sham Comparator: 3

Primary Measures

• Caregiver completed questionnaire
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Investigator symptom assessment (efficacy)
  • Time Frame: 8 weeks
    Safety Issue?: No
• Adverse event reporting (safety)
  • Time Frame: 8 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Male or female outpatients age 30 days up to 1 year at Visit 1
• Subjects must have a documented medical diagnosis of 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 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 NICU 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 an 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 1 Year

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Braintree Laboratories

Overall Clinical Trial Officials and Contacts

John McGowan Study Director Braintree Laboratories, Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00373334

Study ID Number: BLI-AX-001

ClinicalTrials.gov Identifier: NCT00373334

Health Authority: United States: Food and Drug Administration