Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD - Full Text View

Sponsor:	Wyeth
Collaborator:	Nycomed
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00259012

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: pantoprazole sodium enteric-coated spheroid suspension	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
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

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

Characterization of PK and PD profile of single and multiple doses of pantoprazole [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of safety and tolerability of pantoprazole [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	92
Study Start Date:	November 2005
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Arm 1- Low Dose pantoprazole	Drug: pantoprazole sodium enteric-coated spheroid suspension pediatric suspension taken daily x 7 days - 333; pediatric suspension taken daily x 6 weeks - 335
2: Active Comparator Arm 2- active drug - pantoprazole	Drug: pantoprazole sodium enteric-coated spheroid suspension pediatric suspension taken daily x 7 days - 333; pediatric suspension taken daily x 6 weeks - 335

Eligibility

Ages Eligible for Study:	1 Month to 11 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259012

Show 31 Study Locations

Sponsors and Collaborators

Wyeth

Nycomed

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Australia, medinfo@wyeth.com
Principal Investigator:	Trial Manager	For Belgium, trials-BEL@wyeth.com
Principal Investigator:	Trial Manager	For France, infomedfrance@wyeth.com
Principal Investigator:	Trial Manager	For Germany, medinfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For Italy, descresg@wyeth.com
Principal Investigator:	Trial Manager	For Poland, WPWZMED@wyeth.com
Principal Investigator:	Trial Manager	For Switzerland, med@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3001B3-333, 3001B3-335
Study First Received:	November 23, 2005
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00259012 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

GERD
Infant

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Gastrointestinal Diseases
Therapeutic Uses
Pantoprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Esophageal Diseases
Gastroesophageal Reflux
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010