Open Label Safety Study of Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD

This study has been completed.

First Received: March 20, 2009 Last Updated: March 23, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00868296

Purpose

The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Patients eligible are who successfully completed the 3001B3-331 or 3001B3-333 studies.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: pantoprazole	Phase III

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety as measured by adverse events and laboratory test results (hematology, blood chemistry, urinalysis, serum gastrin, and infant growth). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	March 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Successful completion of the 3001B3-331 NCT00362609 or 3001B3-333 NCT00259012 Study.

Exclusion Criteria:

Patients requiring chronic use of warfarin, carbamepazine, or phenytoin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868296

Show 72 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

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

More Information

No publications provided

Responsible Party:	Wyeth Research ( Gail Comer/ Medical Monitor )
Study ID Numbers:	3001B3-335
Study First Received:	March 20, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00868296 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Safety

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Pantoprazole
Esophageal Diseases
Gastroesophageal Reflux

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 May 07, 2009