Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

This study has been completed.
Sponsor:
Collaborator:
Nycomed
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00259012
First received: November 23, 2005
Last updated: April 19, 2010
Last verified: April 2010

November 23, 2005
April 19, 2010
November 2005
March 2008   (final data collection date for primary outcome measure)
  • Peak Concentration (Cmax) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Pharmacokinetic (PK) parameters, including peak plasma concentration, were determined following a single oral dose of pantoprazole
  • Time to Peak Concentration (Tmax) Profile [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Pharmacokinetic (PK) parameters, including time to peak plasma concentration, were determined following a single oral dose of pantoprazole.
  • Disposition Half-life [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.
  • Area Under the Concentration-time Curve (AUC) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.
  • Apparent Oral Clearance (CL/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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.
  • Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Plasma concentration of pantoprazole after multiple doses was measured to see if there was any accumulation of the drug.
  • Intragastric pH [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).
  • Median Intragastric pH [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).
  • Percentage of Time Intragastric pH Was >4 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).
  • Mean Intraesophageal pH [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).
  • Median Intraesophageal pH [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).
  • Percentage of Time That Intraesophageal pH Was <4 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).
  • Normalized Area of Gastric Hydrogen Ion Activity Over Time [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.
  • Normalized Area of Esophageal Hydrogen Ion Activity Over Time [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.
Characterization of PK and PD profile of single and multiple doses of pantoprazole
Complete list of historical versions of study NCT00259012 on ClinicalTrials.gov Archive Site
Not Provided
Assessment of safety and tolerability of pantoprazole
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux
Drug: pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
  • Active Comparator: Low dose
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension
  • Active Comparator: High dose
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension
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 1;50(8):541-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
March 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
1 Month to 11 Months
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   France,   Germany,   Italy,   Poland,   Switzerland
 
NCT00259012
3001B3-333, 3001B3-335
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Nycomed
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
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP