Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD) - Full Text View

Sponsors and Collaborators:	Wyeth Nycomed
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00300755

Purpose

To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.

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

MedlinePlus related topics: Dietary Sodium GERD

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary efficacy outcome is the weekly GERD symptom score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
individual mean frequency of each GERD symptom [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
individual mean score for respiratory symptoms [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
change in endoscopy results at end of study in patients with a second endoscopy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	65
Study Start Date:	April 2006
Study Completion Date:	April 2008
Primary Completion Date:	April 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 pediatric spheriods taken daily x 8 weeks
2: Active Comparator Arm 2- Medium Dose pantoprazole	Drug: pantoprazole sodium enteric-coated spheroid pediatric spheriods taken daily x 8 weeks
3: Active Comparator Arm 3- High Dose pantoprazole	Drug: pantoprazole sodium enteric-coated spheroid pediatric spheriods taken daily x 8 weeks

Eligibility

Ages Eligible for Study:	1 Year to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ability to undergo endoscopy with required biopsy
Ages 1 through 5 years
Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.

Exclusion Criteria:

History or presence of upper gastrointestinal anatomic or motor disorders
Known current or active cow` s milk allergy
Malignancy Other exclusions apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300755

Show 43 Study Locations

Sponsors and Collaborators

Wyeth

Nycomed

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3001B3-328
Study First Received:	March 7, 2006
Last Updated:	July 22, 2008
ClinicalTrials.gov Identifier:	NCT00300755
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

GERD
Children
Child
Child, Preschool

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 15, 2009