Clinical trial NCT00141817: Study Evaluating Pantoprazole in Children With GERD
Official title: A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: Gastrointestinal Reflux Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 41
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.


Eligibility criteria: Inclusion Criteria:

* Endoscopically proven GERD diagnosed within 6 months before study entry.
* Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Exclusion Criteria:

* History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
* Subjects 6-11 years old unable to swallow tablets

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
timeFrame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
measure: Apparent Oral Clearance (CL/F)
timeFrame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
measure: Terminal-Phase Volume of Distribution (Vz/F)
timeFrame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
measure: Plasma Concentrations After Multiple Doses
timeFrame: Hours 2 and 4 on Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Park Ridge
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Brockton
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
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: Cincinnati
country: United States
state: Ohio
city: Memphis
country: United States
state: Tennessee
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
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.