Clinical trial NCT00365300: Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: GERD
Infants
Gastroesophageal Reflux
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-17
Enrollment: 129
Sex: ALL
Minimum age (years): 28
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).


Eligibility criteria: Inclusion Criteria:

* term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
* clinical diagnosis of GERD
* weight greater than 2.5 kg and less than or equal to 15 kg

Exclusion Criteria:

* known history of upper GI anatomic disorders
* history of acute life-threatening medical conditions
* clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Number of Patients Withdrawn From Study Due to Lack of Efficacy.
timeFrame: 4 weeks double-blind
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Peoria
country: United States
state: Illinois
city: Bardstown
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Flint
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: Camden
country: United States
state: New Jersey
city: Mays Landing
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Bethlehem
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Huntington
country: United States
state: West Virginia
city: Morgantown
country: United States
state: West Virginia
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: