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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00259012
Registration number
NCT00259012
Ethics application status
Date submitted
23/11/2005
Date registered
28/11/2005
Date last updated
7/05/2010
Titles & IDs
Public title
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
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Scientific 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
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Secondary ID [1]
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3001B3-333, 3001B3-335
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal Reflux
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - pantoprazole sodium enteric-coated spheroid suspension
Active Comparator: Low dose -
Active Comparator: High dose -
Treatment: Drugs: pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Peak Concentration (Cmax)
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Assessment method [1]
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Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
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Timepoint [1]
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1 day
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Primary outcome [2]
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Time to Peak Concentration (Tmax) Profile
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Assessment method [2]
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Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
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Timepoint [2]
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1 day
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Primary outcome [3]
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Disposition Half-life
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Assessment method [3]
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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.
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Timepoint [3]
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1 day
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Primary outcome [4]
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Area Under the Concentration-time Curve (AUC)
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Assessment method [4]
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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.
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Timepoint [4]
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1 day
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Primary outcome [5]
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Apparent Oral Clearance (CL/F)
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Assessment method [5]
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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.
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Timepoint [5]
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1 day
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Primary outcome [6]
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Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
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Assessment method [6]
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Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
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Timepoint [6]
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7 days
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Primary outcome [7]
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Intragastric pH
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Assessment method [7]
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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).
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Timepoint [7]
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7 days
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Primary outcome [8]
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Median Intragastric pH
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Assessment method [8]
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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).
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Timepoint [8]
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7 days
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Primary outcome [9]
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Percentage of Time Intragastric pH Was >4
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Assessment method [9]
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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).
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Timepoint [9]
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7 days
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Primary outcome [10]
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Mean Intraesophageal pH
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Assessment method [10]
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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).
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Timepoint [10]
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7 days
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Primary outcome [11]
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Median Intraesophageal pH
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Assessment method [11]
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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).
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Timepoint [11]
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7 days
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Primary outcome [12]
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Percentage of Time That Intraesophageal pH Was <4
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Assessment method [12]
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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).
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Timepoint [12]
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7 days
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Primary outcome [13]
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Normalized Area of Gastric Hydrogen Ion Activity Over Time
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Assessment method [13]
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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.
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Timepoint [13]
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7 days
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Primary outcome [14]
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Normalized Area of Esophageal Hydrogen Ion Activity Over Time
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Assessment method [14]
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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.
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Timepoint [14]
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7 days
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Eligibility
Key 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
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Minimum age
1
Month
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Maximum age
11
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal
fistula, GI malabsorption
- Clinically significant medical or surgical abnormalities
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
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Accrual to date
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Final
67
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Brisbane
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Recruitment postcode(s) [1]
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- Brisbane
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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District of Columbia
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Country [4]
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Kentucky
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Country [7]
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United States of America
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State/province [7]
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Louisiana
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Country [8]
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United States of America
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State/province [8]
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Mississippi
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Country [9]
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United States of America
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State/province [9]
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Missouri
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Country [10]
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United States of America
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State/province [10]
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New York
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Country [11]
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United States of America
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State/province [11]
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North Carolina
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Country [12]
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United States of America
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State/province [12]
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Ohio
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Country [13]
0
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United States of America
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State/province [13]
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Texas
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Country [14]
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Belgium
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State/province [14]
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Antwerpen
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Country [15]
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Belgium
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State/province [15]
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Brussels
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Country [16]
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Belgium
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State/province [16]
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Gent
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Country [17]
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France
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State/province [17]
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Paris
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Country [18]
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Germany
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State/province [18]
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Aachen
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Country [19]
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Germany
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State/province [19]
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Osnabruck
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Country [20]
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Italy
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State/province [20]
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Brescia
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Country [21]
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Italy
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State/province [21]
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Naples
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Country [22]
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Italy
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State/province [22]
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Roma
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Country [23]
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Poland
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State/province [23]
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Krakow
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Country [24]
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Poland
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State/province [24]
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Lodz
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Country [25]
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Poland
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State/province [25]
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Lublin
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Country [26]
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Poland
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State/province [26]
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Warszaw
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Country [27]
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Switzerland
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State/province [27]
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Zurich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Wyeth is now a wholly owned subsidiary of Pfizer
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Nycomed
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00259012
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Wyeth is now a wholly owned subsidiary of Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00259012
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