A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
Information source: TAP Pharmaceutical Products Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease
Intervention: lansoprazole suspension (Drug); lansoprazole suspension (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: TAP Pharmaceutical Products Inc. Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: TAP Pharmaceutical Products Inc.
Summary
The study is being conducted to understand how quickly the study drug works to improve
feeding and to study the safety of the drug in premature babies or babies less than 28 days
of age.
Clinical Details
Official title: A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Infants With Clinically-Evident Gastroesophageal Reflux Disease.
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Pharmacokinetic analysis.Mean intragastric 24 hour pH (subset of 6 subjects)
Secondary outcome: GERD symptom assessment.
Detailed description:
A Phase 1, multicenter, pharmacokinetic/Pharmacodynamic and safety study in which infants
will be randomized in an open-label fashion to receive 5 days of open-label treatment with
lansoprazole pediatric suspension 1 mg/kg/day oral, or lansoprazole pediatric suspension 2
mg/kg/day oral. On Dosing Days 1 and 5, blood samples will be obtained for drug assay. All
subjects will be evaluated for inclusion in the pH monitoring portion of the study and will
undergo pH monitoring, provided it is clinically indicated, at the discretion of the
investigator. Intragastric pH monitoring (up to 24 hours) will be performed at Baseline, on
Dosing Day 1 (or Day 2) and on Dosing Day 5 (or Day 6). Intraesophageal pH may be done in
addition to intragastric pH at the discretion of the investigator. Subjects will be evaluated
for safety, including a follow-up visit on Post-Dosing Day 14.
Eligibility
Minimum age: N/A.
Maximum age: 364 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hospitalized or outpatient male or female, term or post-term infants beyond the
neonatal period (>28 days) but less than 12 months of age, OR a preterm infant with a
corrected age of at least 44 weeks but less than 12 months on Dosing Day 1.
- Clinically-evident GERD (feeding intolerance, regurgitation, wheezing or stridor with
feedings)
- At least 7 days post-surgery without anticipated need for surgery during study
- No significant laboratory abnormalities
Exclusion Criteria:
- Unstable, clinically significant disease or abnormality
- Congenital anomaly of the upper gastrointestinal tract
- Clinical evidence of acute sepsis
- Cystic fibrosis
- Medical condition requiring subject to not be fed by mouth/gastric tube
Locations and Contacts
Additional Information
Trial results can be found on this link: For FDA Safety Alerts and Recalls, refer to this link: For the Prevacid Package Insert, refer to this link:
Starting date: January 2005
Ending date: July 2005
Last updated: June 13, 2008
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