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

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 gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease; GERD; Heartburn
• Intervention / Treatment: Drug: placebo; Drug: nizatidine (axid)

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
    • Jonesboro, Arkansas, United States, 72401
    • Little Rock, Arkansas, United States, 72211
    • Little Rock, Arkansas, United States, 72205
    • Searcy, Arkansas, United States
  • California
    • Madiera, California, United States
  • Colorado
    • Centennial, Colorado, United States, 80112
  • Florida
    • Orlando, Florida, United States
    • Panama City, Florida, United States, 32405
    • Tampa, Florida, United States, 33603
  • Georgia
    • Tifton, Georgia, United States
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Fairfield, Ohio, United States, 45014
    • Mason, Ohio, United States, 45040
  • Pennsylvania
    • Hershey, Pennsylvania, United States
    • Pittsburgh, Pennsylvania, United States, 15202
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
  • Texas
    • Houston, Texas, United States, 77004
    • Missouri City, Texas, United States, 77495
    • Temple, Texas, United States, 76502
  • Utah
    • Ogden, Utah, United States, 84405
    • South Jordan, Utah, United States, 84095

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: nizatidine (axid); nizatidine (axid)
Experimental: 2	Drug: nizatidine (axid); nizatidine (axid)
Sham Comparator: 3	Drug: placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success	The I-GERQ-R contains 12 questions assessing gastroesophageal reflux disease (GERD) frequency and severity. A low I-GERQ-R score (minimum = 0) indicates minimal symptoms and a high I-GERQ-R score (maximum = 42) indicates more frequent and/or severe symptoms. Success is defined as a reduction in I-GERQ-R score of at least 5 points from baseline, provided a subject did not discontinue due to lack of efficacy or adverse event, and had been treated for at least 4 weeks.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief	Subjective investigator assessment of GERD relief - rating categories were BETTER, NO CHANGE, or WORSE from baseline.	8 weeks
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity	Subjective investigator assessment of GERD severity - rating categories were NONE, MILD, MODERATE, or SEVERE.	8 weeks

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: September 7, 2006
• First Submitted That Met QC Criteria: September 7, 2006
• First Posted (Estimate): September 8, 2006

Study Record Updates

• Last Update Posted (Estimate): November 18, 2009
• Last Update Submitted That Met QC Criteria: November 17, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: GERD; gastroesophageal reflux disease; heartburn
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Nizatidine
• Other Study ID Numbers: BLI-AX-001