Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

pantoprazole

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring Safety

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Low dose

High dose

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT00362609

First Posted

August 8, 2006

Last Updated

April 22, 2010

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00362609

Brief Title

Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux

Keywords

Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose

Arm Type

Active Comparator

Arm Title

High dose

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

pantoprazole

Primary Outcome Measure Information:

Title

Variance of Oral Bioavailability

Description

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.

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Area Under the Concentration-time Curve (AUC)

Description

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.

Time Frame

Baseline to 24 hours post dose on Day 1

Title

Apparent Oral Clearance (Cl/F)

Description

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.

Time Frame

1 day

Title

Half Life

Description

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.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

28 Days

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials: