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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief [ Time Frame: 8 weeks ]
2. Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity [ Time Frame: 8 weeks ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 26 Study Locations

Sponsors and Collaborators

Braintree Laboratories

Investigators

Study Director:	John McGowan	Braintree Laboratories, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	John McGowan, Clinical Operations Manager, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier:	NCT00373334 History of Changes
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; Heartburn; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms	Nizatidine; Anti-Ulcer Agents; Gastrointestinal Agents; Histamine H2 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs