Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

April 22, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia
  • Belgium
      • Edegem, Belgium, 2650
      • Leuven, Belgium, 3000
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
      • Toronto, Ontario, Canada, M5G 1X8
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
      • Sainte-Foy, Quebec, Canada, G1V 4G2
  • France
      • Paris Cedex, France, 75674
      • Paris Cedex, France, 75935
  • Germany
      • Bochum, Germany, 44797
      • Osnabrueck, Germany, 49074
      • Potsdam, Germany, 14467
  • Italy
      • Brescia, Italy, 25123
      • Napoli, Italy, 80121
      • Roma, Italy, 00161
  • Netherlands
      • Rotterdam, Netherlands, 3015 GJ
  • Poland
      • Bydgoszcz, Poland, 85-165
      • Krakow, Poland, 33-663
      • Lublin, Poland, 20-093
  • South Africa
      • Durban, South Africa, 3630
      • Overport, South Africa, 4067
      • Pretoria, South Africa, 0083
    • CPT
      • Panorama, CPT, South Africa, 7500
    • KZN
      • Pietermaritzburg, KZN, South Africa, 3235
  • Switzerland
      • Zurich, Switzerland, 8032
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • California
      • Loma Linda, California, United States, 92354
      • Oakland, California, United States, 94609-1809
      • Orange, California, United States, 92868
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92103
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8064
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32610-0296
      • Miami, Florida, United States, 33101
      • Sunrise, Florida, United States, 33323
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
    • Idaho
      • Boise, Idaho, United States, 83704
    • Illinois
      • Chicago, Illinois, United States, 60614
      • Park Ridge, Illinois, United States, 60068
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Flint, Michigan, United States, 48503
    • Nebraska
      • Omaha, Nebraska, United States, 68105
    • New Jersey
      • Camden, New Jersey, United States, 08103
      • New Brunswick, New Jersey, United States, 08901
      • Newark, New Jersey, United States, 07103
    • New York
      • Albany, New York, United States, 12208
      • Bronx, New York, United States, 10467
      • Brooklyn, New York, United States, 11219
      • New York, New York, United States, 10032
      • Valhalla, New York, United States, 10595-1689
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Winston-Salem, North Carolina, United States, 27157
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97239-3042
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-1320
    • Tennessee
      • Memphis, Tennessee, United States, 38163
      • Nashville, Tennessee, United States, 37232-9550
    • Texas
      • Dallas, Texas, United States, 75390-9063
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84113
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Richmond, Virginia, United States, 23298
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High dose
Drug: pantoprazole
Active Comparator: Low dose
Drug: pantoprazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variance of Oral Bioavailability
Time Frame: 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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-time Curve (AUC)
Time Frame: 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.
Baseline to 24 hours post dose on Day 1
Apparent Oral Clearance (Cl/F)
Time Frame: 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.
1 day
Half Life
Time Frame: 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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For Australia, medinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com
  • Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Switzerland, med@wyeth.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (Estimate)

August 10, 2006

Study Record Updates

Last Update Posted (Estimate)

May 14, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3001B3-331, 3001B3-335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe