Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Condition(s) targeted: Gastroesophageal Reflux

Intervention: pantoprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, medinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For South Africa, ZAFinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Australia, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For France, infomedfrance@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Italy, descresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Switzerland, med@wyeth.com

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

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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: To determine whether or not consistent drug levels can be achieved in neonates and preterm infants with presumed GERD receiving oral doses of pantoprazole.

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

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

Brisbane, Australia

Leuven 3000, Belgium

Edegem 2650, Belgium

Paris Cedex 75935, France

Paris Cedex 75674, France

Osnabrueck 49074, Germany

Potsdam 14467, Germany

Bochum 44797, Germany

Napoli 80121, Italy

Brescia 25123, Italy

Roma 00161, Italy

Rotterdam 3015 GJ, Netherlands

Lublin 20-093, Poland

Bydgoszcz 85-165, Poland

Krakow 33-663, Poland

Durban 3630, South Africa

Overport 4067, South Africa

Pretoria 0083, South Africa

Zurich 8032, Switzerland

Phoenix, Arizona 85006, United States

Vancouver, British Columbia V6H 3V4, Canada

Panorama, CPT 7500, South Africa

San Diego, California 92103, United States

Orange, California 92868, United States

Sacramento, California 95817, United States

Oakland, California 94609-1809, United States

Loma Linda, California 92354, United States

New Haven, Connecticut 06520-8064, United States

Washington, District of Columbia 20010, United States

Miami, Florida 33101, United States

Sunrise, Florida 33323, United States

Gainesville, Florida 32610-0296, United States

Sunrise, Florida 33323, United States

Atlanta, Georgia 30322, United States

Honolulu, Hawaii 96826, United States

Boise, Idaho 83704, United States

Park Ridge, Illinois 60068, United States

Chicago, Illinois 60614, United States

Pietermaritzburg, KZN 3235, South Africa

Lexington, Kentucky 40536-0284, United States

Louisville, Kentucky 40202, United States

New Orleans, Louisiana 70121, United States

Baltimore, Maryland 21201, United States

Boston, Massachusetts 02114, United States

Flint, Michigan 48503, United States

Omaha, Nebraska 68105, United States

Newark, New Jersey 07103, United States

New Brunswick, New Jersey 08901, United States

Camden, New Jersey 08103, United States

New York, New York 10032, United States

Valhalla, New York 10595-1689, United States

Bronx, New York 10467, United States

Albany, New York 12208, United States

Brooklyn, New York 11219, United States

Durham, North Carolina 27710, United States

Winston-Salem, North Carolina 27157, United States

Oklahoma City, Oklahoma 73104, United States

Ottawa, Ontario K1Y 4E9, Canada

Toronto, Ontario M5G 1X8, Canada

Portland, Oregon 97239-3042, United States

Danville, Pennsylvania 17822-1320, United States

Montreal, Quebec H3H 1P3, Canada

Sainte-Foy, Quebec G1V 4G2, Canada

Memphis, Tennessee 38163, United States

Nashville, Tennessee 37232-9550, United States

Dallas, Texas 75390-9063, United States

San Antonio, Texas 78229, United States

Salt Lake City, Utah 84113, United States

Burlington, Vermont 05401, United States

Richmond, Virginia 23298, United States

Morgantown, West Virginia 26506, United States

Milwaukee, Wisconsin 53226, United States

Starting date: July 2006
Ending date: December 2007
Last updated: February 4, 2008