Clinical trial NCT00362609: Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
Official title: A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: Safety
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-10
Enrollment: 59
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients
* Presumed diagnosis of GERD
* Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks

Exclusion Criteria:

* cardiovascular instability
* clinically significant laboratory abnormalities
* use of warfarin, carbamazepine, phenytoin, or rifampin

Primary outcomes:
measure: Variance of Oral Bioavailability
timeFrame: 1 day
Secondary outcomes:
measure: Area Under the Concentration-time Curve (AUC)
timeFrame: Baseline to 24 hours post dose on Day 1
measure: Apparent Oral Clearance (Cl/F)
timeFrame: 1 day
measure: Half Life
timeFrame: 1 day
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Loma Linda
country: United States
state: California
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: New Haven
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Sunrise
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Flint
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Camden
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Bronx
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Valhalla
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Danville
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Brisbane
country: Australia
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Vancouver
country: Canada
state: British Columbia
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: Paris Cedex
country: France
city: Paris Cedex
country: France
city: Bochum
country: Germany
city: Osnabrueck
country: Germany
city: Potsdam
country: Germany
city: Brescia
country: Italy
city: Napoli
country: Italy
city: Roma
country: Italy
city: Rotterdam
country: Netherlands
city: Bydgoszcz
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Panorama
country: South Africa
state: CPT
city: Pietermaritzburg
country: South Africa
state: KZN
city: Durban
country: South Africa
city: Overport
country: South Africa
city: Pretoria
country: South Africa
city: Zurich
country: Switzerland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Netherlands, trials-NL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For South Africa, ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Switzerland, med@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References: