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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
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux
Drug: pantoprazole sodium enteric-coated spheroid suspension
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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.


Enrollment: 67
Study Start Date: November 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low dose Drug: pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
Active Comparator: High dose Drug: pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days

  Eligibility

Ages Eligible for Study:   1 Month to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259012

  Show 31 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Nycomed
Investigators
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
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00259012     History of Changes
Other Study ID Numbers: 3001B3-333, 3001B3-335
Study First Received: November 23, 2005
Results First Received: November 30, 2009
Last Updated: April 19, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
GERD
Infant

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Pantoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014