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
1 other identifier
interventional
138
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2006
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 7, 2006
CompletedFirst Posted
Study publicly available on registry
September 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
November 17, 2009
CompletedNovember 18, 2009
November 1, 2009
1.5 years
September 7, 2006
August 3, 2009
November 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Relief
8 weeks
Investigator Assessment of Gastroesophageal Reflux Disease (GERD) Severity
8 weeks
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Hot Springs, Arkansas, 71913, United States
Unknown Facility
Jonesboro, Arkansas, 72401, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Little Rock, Arkansas, 72211, United States
Unknown Facility
Searcy, Arkansas, United States
Unknown Facility
Madiera, California, United States
Unknown Facility
Centennial, Colorado, 80112, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Panama City, Florida, 32405, United States
Unknown Facility
Tampa, Florida, 33603, United States
Unknown Facility
Tifton, Georgia, United States
Unknown Facility
Owensboro, Kentucky, 42303, United States
Unknown Facility
Shreveport, Louisiana, 71105, United States
Unknown Facility
Lincoln, Nebraska, 68505, United States
Unknown Facility
Bismarck, North Dakota, 58501, United States
Unknown Facility
Fargo, North Dakota, 58103, United States
Unknown Facility
Fairfield, Ohio, 45014, United States
Unknown Facility
Mason, Ohio, 45040, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15202, United States
Unknown Facility
Clarksville, Tennessee, 37043, United States
Unknown Facility
Houston, Texas, 77004, United States
Unknown Facility
Missouri City, Texas, 77495, United States
Unknown Facility
Temple, Texas, 76502, United States
Unknown Facility
Ogden, Utah, 84405, United States
Unknown Facility
South Jordan, Utah, 84095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Operations Manager
- Organization
- Braintree Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
John McGowan
Braintree Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2006
First Posted
September 8, 2006
Study Start
August 1, 2006
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
November 18, 2009
Results First Posted
November 17, 2009
Record last verified: 2009-11