Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
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
1 other identifier
interventional
67
8 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2005
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 23, 2005
CompletedFirst Posted
Study publicly available on registry
November 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
May 7, 2010
CompletedMay 7, 2010
April 1, 2010
2.3 years
November 23, 2005
November 30, 2009
April 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (14)
Peak Concentration (Cmax)
Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
1 day
Time to Peak Concentration (Tmax) Profile
Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
1 day
Disposition Half-life
Pharmacokinetic (PK) parameters, including the terminal-phase disposition half-life, were determined following a single oral dose of pantoprazole. Half-life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes.
1 day
Area Under the Concentration-time Curve (AUC)
Pharmacokinetic (PK) parameters, including AUC, were determined following a single oral dose of pantoprazole. AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
1 day
Apparent Oral Clearance (CL/F)
Pharmacokinetic (PK) parameters, including apparent oral clearance, were determined following a single oral dose of pantoprazole. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
1 day
Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
7 days
Intragastric pH
Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
7 days
Median Intragastric pH
Intragastric pH is a method for evaluating gastric acidity scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
7 days
Percentage of Time Intragastric pH Was >4
Intragastric pH is a method for evaluating gastric acidity. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
7 days
Mean Intraesophageal pH
Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
7 days
Median Intraesophageal pH
Intraesophagel pH is a method for evaluating acidity of gastric refluxate scaled 0-9. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
7 days
Percentage of Time That Intraesophageal pH Was <4
Intraesophagel pH is a method for evaluating acidity of gastric refluxate. A lower pH means more acidity. A longer duration of esophageal mucosa exposure to a gastric refluxate with a pH \<4.0 correlates with more severe mucosal injury in patients with gastroesophageal reflux disease (GERD).
7 days
Normalized Area of Gastric Hydrogen Ion Activity Over Time
Normalized Area of Gastric Hydrogen Ion Activity Over Time is a measure of the area under the curve of the gastric hydrogen ion activity over time, which is normalized for a 24-hour period.
7 days
Normalized Area of Esophageal Hydrogen Ion Activity Over Time
Normalized Area of Esophageal Hydrogen Ion Activity Over Time is a measure of the area under the curve of the esophageal hydrogen ion activity over time, which is normalized for a 24-hour period.
7 days
Study Arms (2)
Low dose
ACTIVE COMPARATORHigh dose
ACTIVE COMPARATORInterventions
pediatric suspension taken daily x 7 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
- Clinically significant medical or surgical abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizerlead
- Nycomedcollaborator
Study Sites (31)
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Loma Linda, California, 92351, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Miami, Florida, 33101, United States
Unknown Facility
Pensacola, Florida, 32504, United States
Unknown Facility
Chicago, Illinois, 60614, United States
Unknown Facility
Park Ridge, Illinois, 60068, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Shreveport, Louisiana, 71130, United States
Unknown Facility
Jackson, Mississippi, 39216, United States
Unknown Facility
Kansas City, Missouri, 64108, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cleveland, Ohio, 44106, United States
Unknown Facility
Temple, Texas, 76508, United States
Unknown Facility
Brisbane, Australia
Unknown Facility
Antwerp, B-2020, Belgium
Unknown Facility
Brussels, B-1090, Belgium
Unknown Facility
Ghent, B-9000, Belgium
Unknown Facility
Paris, 75674, France
Unknown Facility
Aachen, D-52074, Germany
Unknown Facility
Osnabrück, D-49074, Germany
Unknown Facility
Brescia, 25123, Italy
Unknown Facility
Naples, 80131, Italy
Unknown Facility
Roma, 00161, Italy
Unknown Facility
Krakow, 30-663, Poland
Unknown Facility
Lodz, 91-738, Poland
Unknown Facility
Lublin, Poland
Unknown Facility
Warsaw, 04-730, Poland
Unknown Facility
Zurich, 8032, Switzerland
Related Publications (1)
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.
PMID: 21740077DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Australia, medinfo@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Belgium, trials-BEL@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For France, infomedfrance@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Germany, medinfoDEU@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Italy, descresg@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Poland, WPWZMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Switzerland, med@wyeth.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 23, 2005
First Posted
November 28, 2005
Study Start
November 1, 2005
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
May 7, 2010
Results First Posted
May 7, 2010
Record last verified: 2010-04