Clinical trial NCT00300755: Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: GERD
Children
Child
Child, Preschool
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Nycomed
First posted: 2006-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Change in Weekly Gastroesophageal Reflux Disease (GERD) Symptom Scores (WGSS)
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Individual Weekly Mean Frequency Score for Each Gastroesophageal Reflux Disease (GERD) Symptom Score From Baseline to Final Week
timeFrame: Baseline and 8 weeks
measure: Change in Individual Weekly Mean Score For Each Respiratory Symptom From Baseline
timeFrame: Baseline and 8 weeks
measure: Number of Patients With "Healed" Erosive Esophagitis (EE) at End of Study
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Wilmington
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Peoria
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Flint
country: United States
state: Michigan
city: Southfield
country: United States
state: Michigan
city: Jackson
country: United States
state: Mississippi
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Egg Harbor Township
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: New York
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Danville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Charleston
country: United States
state: West Virginia
city: Huntington
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Edmonton
country: Canada
state: Alberta
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Hamilton
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Baker R, Tsou VM, Tung J, Baker SS, Li H, Wang W, Rath N, Maguire MK, Comer GM. Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. Clin Pediatr (Phila). 2010 Sep;49(9):852-65. doi: 10.1177/0009922810369253. Epub 2010 Jun 3.