Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Gastroesophageal Reflux Clinical Trial

Official title:

A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362609
• Other study ID #: 3001B3-331, 3001B3-335
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2006
• Last updated: April 22, 2010
• Start date: July 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• pantoprazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Poland,  South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variance of Oral Bioavailability	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.	1 day	No
Secondary	Area Under the Concentration-time Curve (AUC)	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.	Baseline to 24 hours post dose on Day 1	No
Secondary	Apparent Oral Clearance (Cl/F)	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.	1 day	No
Secondary	Half Life	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.	1 day	No