Clinical trial NCT00259012: Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
Official title: A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: GERD
Infant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Nycomed
First posted: 2005-11-28
Enrollment: 67
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Eligibility criteria: Inclusion Criteria:

* Greater than 44 weeks beyond neonatal period but less than 12 months
* Presumptive diagnosis of GERD
* Weight greater than 2.5 kg but less than 15 kg

Exclusion Criteria:

* History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
* Clinically significant medical or surgical abnormalities

Primary outcomes:
measure: Peak Concentration (Cmax)
timeFrame: 1 day
measure: Time to Peak Concentration (Tmax) Profile
timeFrame: 1 day
measure: Disposition Half-life
timeFrame: 1 day
measure: Area Under the Concentration-time Curve (AUC)
timeFrame: 1 day
measure: Apparent Oral Clearance (CL/F)
timeFrame: 1 day
measure: Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
timeFrame: 7 days
measure: Intragastric pH
timeFrame: 7 days
measure: Median Intragastric pH
timeFrame: 7 days
measure: Percentage of Time Intragastric pH Was >4
timeFrame: 7 days
measure: Mean Intraesophageal pH
timeFrame: 7 days
measure: Median Intraesophageal pH
timeFrame: 7 days
measure: Percentage of Time That Intraesophageal pH Was <4
timeFrame: 7 days
measure: Normalized Area of Gastric Hydrogen Ion Activity Over Time
timeFrame: 7 days
measure: Normalized Area of Esophageal Hydrogen Ion Activity Over Time
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Loma Linda
country: United States
state: California
city: San Diego
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Louisville
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Temple
country: United States
state: Texas
city: Brisbane
country: Australia
city: Antwerpen
country: Belgium
city: Brussels
country: Belgium
city: Gent
country: Belgium
city: Paris
country: France
city: Aachen
country: Germany
city: Osnabruck
country: Germany
city: Brescia
country: Italy
city: Naples
country: Italy
city: Roma
country: Italy
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Warszaw
country: Poland
city: Zurich
country: Switzerland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Australia, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, descresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Switzerland, med@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000.