Safety and Efficacy Study of Axid Use in Infants Suffering From GERD
Information source: Braintree Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease; GERD; Heartburn
Intervention: nizatidine (axid) (Drug); placebo (Other)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Braintree Laboratories Official(s) and/or principal investigator(s):
John McGowan, Study Director, Affiliation: Braintree Laboratories, Inc.
Summary
The objective of this study is to evaluate the efficacy,acceptability, and safety of Axid
Oral Solution versus placebo in the treatment of GERD in infants age 30 days up to 1 year.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Caregiver completed questionnaire
Secondary outcome: Investigator symptom assessment (efficacy)Adverse event reporting (safety)
Eligibility
Minimum age: N/A.
Maximum age: 1 Year.
Gender(s): Both.
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 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
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 NICU 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 an 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.
Locations and Contacts
Little Rock, Arkansas 72205, United States
Jonesboro, Arkansas 72401, United States
Hot Springs, Arkansas 71913, United States
Little Rock, Arkansas 72211, United States
Searcy, Arkansas, United States
Madiera, California, United States
Centennial, Colorado 80112, United States
Tampa, Florida 33603, United States
Panama City, Florida 32405, United States
Orlando, Florida, United States
Tifton, Georgia, United States
Owensboro, Kentucky 42303, United States
Shreveport, Louisiana 71105, United States
Lincoln, Nebraska 68505, United States
Fargo, North Dakota 58103, United States
Bismarck, North Dakota 58501, United States
Mason, Ohio 45040, United States
Fairfield, Ohio 45014, United States
Pittsburgh, Pennsylvania 15202, United States
Hershey, Pennsylvania, United States
Clarksville, Tennessee 37043, United States
Houston, Texas 77004, United States
Missouri City, Texas 77495, United States
Temple, Texas 76502, United States
Ogden, Utah 84405, United States
South Jordan, Utah 84095, United States
Additional Information
Starting date: August 2006
Ending date: February 2008
Last updated: December 20, 2007
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