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

• ClinicalTrials.gov Identifier: NCT00373334
• Recruitment Status: Completed
• First Posted: September 8, 2006
• Results First Posted: November 17, 2009
• Last Update Posted: November 18, 2009
• Sponsor: Braintree Laboratories
• Information provided by: Braintree Laboratories

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Gastroesophageal Reflux Disease; GERD; Heartburn	Drug: nizatidine (axid); Drug: placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: August 2006
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success [ Time Frame: 8 weeks ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 1 Year (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Arkansas

Hot Springs, Arkansas, United States, 71913

Jonesboro, Arkansas, United States, 72401

Little Rock, Arkansas, United States, 72205

Little Rock, Arkansas, United States, 72211

Searcy, Arkansas, United States

United States, California

Madiera, California, United States

United States, Colorado

Centennial, Colorado, United States, 80112

United States, Florida

Orlando, Florida, United States

Panama City, Florida, United States, 32405

Tampa, Florida, United States, 33603

United States, Georgia

Tifton, Georgia, United States

United States, Kentucky

Owensboro, Kentucky, United States, 42303

United States, Louisiana

Shreveport, Louisiana, United States, 71105

United States, Nebraska

Lincoln, Nebraska, United States, 68505

United States, North Dakota

Bismarck, North Dakota, United States, 58501

Fargo, North Dakota, United States, 58103

United States, Ohio

Fairfield, Ohio, United States, 45014

Mason, Ohio, United States, 45040

United States, Pennsylvania

Hershey, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States, 15202

United States, Tennessee

Clarksville, Tennessee, United States, 37043

United States, Texas

Houston, Texas, United States, 77004

Missouri City, Texas, United States, 77495

Temple, Texas, United States, 76502

United States, Utah

Ogden, Utah, United States, 84405

South Jordan, Utah, United States, 84095

Sponsors and Collaborators

Braintree Laboratories

Investigators

• Study Director: John McGowan; Braintree Laboratories, Inc.

More Information

• Responsible Party: John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
• ClinicalTrials.gov Identifier: NCT00373334
• Other Study ID Numbers: BLI-AX-001
• First Posted: September 8, 2006
• Results First Posted: November 17, 2009
• Last Update Posted: November 18, 2009
• Last Verified: November 2009

Keywords provided by Braintree Laboratories:

gastroesophageal reflux disease; GERD; heartburn

Additional relevant MeSH terms:

Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Nizatidine; Anti-Ulcer Agents; Gastrointestinal Agents; Histamine H2 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs