Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Phase 3

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: pantoprazole

• Registration Number: NCT00362609
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-08
• Study First Submitted QC: 2006-08-08
• Study First Posted: 2006-08-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Disposition First Submitted: 2008-12-17
• Results First Submitted: 2009-11-30
• Status Verified: 2010-04
• Results First Submitted QC: 2010-04-22
• Disposition First Submitted QC: 2010-04-22
• Last Update Submitted: 2010-04-22
• Results First Posted: 2010-05-14
• Disposition First Posted: 2010-05-14
• Last Update Posted: 2010-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Hospitalized patients
• Presumed diagnosis of GERD
• Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks

Exclusion Criteria

• cardiovascular instability
• clinically significant laboratory abnormalities
• use of warfarin, carbamazepine, phenytoin, or rifampin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	pantoprazole	-
High dose	pantoprazole	-

Primary Outcome Measures

Name	Time	Method
Variance of Oral Bioavailability	1 day	Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was \>1.2.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve (AUC)	Baseline to 24 hours post dose on Day 1	AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.
Half Life	1 day	Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.
Apparent Oral Clearance (Cl/F)	1 day	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling.