A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand how quickly lansoprazole, once daily (QD), improves feeding in premature babies or babies less than 28 days of age.

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.

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.

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: Lansoprazole
* Drug: Lansoprazole


Participation Criteria
=================
Eligibility 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 Gastroesophageal Reflux Disease (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

Ages Eligible for Study
-----------------
Minimum Age: 29 Days
Maximum Age: 364 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lansoprazole 1.0 mg/kg QD<br> | Drug: Lansoprazole<br>* Lansoprazole 1.0 mg/kg/day suspension, orally, once daily for up to 5 days.<br>|
| Experimental: Lansoprazole 2.0 mg/kg QD<br> | Drug: Lansoprazole<br>* Lansoprazole 2.0 mg/kg/day suspension, orally, once daily for up to 5 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Analysis. |  | Day 1 and 5 | 
| Mean Intragastric 24 hour pH (subset of 6 subjects) |  | Day -1, 1 and 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastroesophageal Reflux Disease Symptom Assessment. |  | Days 1-5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric GERD, Pediatric Gastroesophageal Reflux Disease, lansoprazole