Clinical trial NCT00373334: Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
GERD
Heartburn
Keywords: gastroesophageal reflux disease
GERD
heartburn
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2006-09-08
Enrollment: 138
Sex: ALL
Minimum age (years): 30
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) Success
timeFrame: 8 weeks
Secondary outcomes:
measure: Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
timeFrame: 8 weeks
measure: Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Jonesboro
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: Searcy
country: United States
state: Arkansas
city: Madiera
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Orlando
country: United States
state: Florida
city: Panama City
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Tifton
country: United States
state: Georgia
city: Owensboro
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Lincoln
country: United States
state: Nebraska
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Fairfield
country: United States
state: Ohio
city: Mason
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Clarksville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Missouri City
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan
role: STUDY_DIRECTOR
References: