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

NCT ID: NCT00373334

Last Updated: 2009-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-02-29

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.

Conditions

Gastroesophageal Reflux Disease; GERD; Heartburn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: EXPERIMENTAL

nizatidine (axid)

Intervention Type: DRUG

nizatidine (axid)

2

Group Type: EXPERIMENTAL

nizatidine (axid)

Intervention Type: DRUG

nizatidine (axid)

3

Group Type: SHAM_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

nizatidine (axid)

nizatidine (axid)

Intervention Type: DRUG

nizatidine (axid)

nizatidine (axid)

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Braintree Laboratories, Inc.

Principal Investigators

John McGowan

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

Hot Springs, Arkansas, United States

Jonesboro, Arkansas, United States

Little Rock, Arkansas, United States

Little Rock, Arkansas, United States

Searcy, Arkansas, United States

Madiera, California, United States

Centennial, Colorado, United States

Orlando, Florida, United States

Panama City, Florida, United States

Tampa, Florida, United States

Tifton, Georgia, United States

Owensboro, Kentucky, United States

Shreveport, Louisiana, United States

Lincoln, Nebraska, United States

Bismarck, North Dakota, United States

Fargo, North Dakota, United States

Fairfield, Ohio, United States

Mason, Ohio, United States

Hershey, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Clarksville, Tennessee, United States

Houston, Texas, United States

Missouri City, Texas, United States

Temple, Texas, United States

Ogden, Utah, United States

South Jordan, Utah, United States

Countries

United States

Other Identifiers

BLI-AX-001

Identifier Type: -

Identifier Source: org_study_id