Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux
Intervention: pantoprazole sodium enteric-coated spheroid suspension (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Australia, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For France, infomedfrance@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, medinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Italy, descresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Poland, WPWZMED@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Switzerland, med@wyeth.com
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic
(PD) profiles to determine the safety and tolerability of single and multiple doses of
pantoprazole in infants aged 1 through 11 months.
Clinical Details
Official title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Characterization of PK and PD profile of single and multiple doses of pantoprazole
Secondary outcome: Assessment of safety and tolerability of pantoprazole
Eligibility
Minimum age: 1 Month.
Maximum age: 11 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Greater than 44 weeks beyond neonatal period but less than 12 months
- Presumptive diagnosis of GERD
- Weight greater than 2. 5 kg but less than 15 kg
Exclusion Criteria:
- History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal
fistula, GI malabsorption
- Clinically significant medical or surgical abnormalities
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Brisbane, Australia; Recruiting
Brussels B-1090, Belgium; Recruiting
Gent B-9000, Belgium; Recruiting
Antwerpen B-2020, Belgium; Recruiting
Paris 75674, France; Recruiting
Aachen D-52074, Germany; Recruiting
Osnabruck D-49074, Germany; Recruiting
Naples 80131, Italy; Recruiting
Brescia 25123, Italy; Recruiting
Roma 00161, Italy; Recruiting
Krakow 30-663, Poland; Recruiting
Lodz 91-738, Poland; Recruiting
Warszaw 04-730, Poland; Recruiting
Lublin, Poland; Recruiting
Zurich 8032, Switzerland; Recruiting
Little Rock, Arkansas 72205, United States; Active, not recruiting
San Diego, California 92103, United States; Active, not recruiting
Loma Linda, California 92351, United States; Not yet recruiting
Washington, District of Columbia 20010, United States; Active, not recruiting
Pensacola, Florida 32504, United States; Active, not recruiting
Miami, Florida 33101, United States; Recruiting
Chicago, Illinois 60614, United States; Recruiting
Park Ridge, Illinois 60068, United States; Active, not recruiting
Louisville, Kentucky 40202, United States; Recruiting
Shreveport, Louisiana 71130, United States; Active, not recruiting
Jackson, Mississippi 39216, United States; Active, not recruiting
Kansas City, Missouri 64108, United States; Completed
New York, New York 10032, United States; Recruiting
Durham, North Carolina 27710, United States; Not yet recruiting
Cleveland, Ohio 44106, United States; Active, not recruiting
Temple, Texas 76508, United States; Completed
Additional Information
Starting date: November 2005
Ending date: April 2008
Last updated: February 4, 2008
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