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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Study Primary Completion Date: July 2005

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.

Intervention(s) in this Clinical Trial

• Drug: lansoprazole suspension
  • 1.0mg/kg/day Suspension orally once daily for 5 Days
• Drug: lansoprazole suspension
  • 2.0mg/kg/day Suspension orally once daily for 5 Days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Pharmacokinetic analysis.
  • Time Frame: Day 1 and 5
    Safety Issue?: No
• Mean intragastric 24 hour pH (subset of 6 subjects)
  • Time Frame: Day -1, 1 and 5
    Safety Issue?: No

Secondary Measures

• GERD symptom assessment.
  • Time Frame: Days 1-5
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 364 Days

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: TAP Pharmaceutical Products Inc.

Overall Clinical Trial Officials and Contacts

Medical Director Study Chair TAP Pharmaceutical Products Inc.  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00220818

Study ID Number: C03-043

ClinicalTrials.gov Identifier: NCT00220818

Health Authority: United States: Food and Drug Administration

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: