Study Evaluating Pantoprazole in Children With GERD - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00141817

Purpose

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: pantoprazole for approximately 9 weeks.	Phase III

MedlinePlus related topics: GERD

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD.

Further study details as provided by Wyeth:

Primary Outcome Measures:

Characterization of the PK profile of single and multiple doses of pantoprazole.

Secondary Outcome Measures:

Assessment of safety and tolerability of pantoprazole and assessment of growth parameters

Estimated Enrollment:	30
Study Start Date:	August 2005
Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	1 Year to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Endoscopically proven GERD diagnosed within 6 months before study entry.
Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Exclusion Criteria:

History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
Subjects 6-11 years old unable to swallow tablets

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141817

Show 23 Study Locations

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3001B3-334
Study First Received:	August 30, 2005
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00141817
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Gastrointestinal Reflux Disease

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:

Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009