A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease

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.

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.

Official title: A Phase 1, Single- and Repeated-Dose, Randomized, Open-Label, Multi-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Lansoprazole in Neonates 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 six subjects)

Secondary outcome: GERD symptom analysis

Detailed description: A Phase 1, multi-center, pharmacokinetic/pharmacodynamic and safety, study in which neonates will be randomized in an open-label fashion to receive 5 days of open-label treatment with either lansoprazole pediatric suspension 1. 0 mg/kg/day orally or lansoprazole pediatric suspension .5 mg/kg/day orally. 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.

Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Neonates in the Neonatal Intensive Care or Special Care Nursery who have been fed

orally or by feeding tube.

- Term or post-term infants with a body weight of >800 gms.

- Pre-term infants with a corrected age of less than 44 weeks.

- 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

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: May 2005
Ending date: August 2005
Last updated: June 13, 2008