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

  Hide Study Locations
Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, California
Loma Linda, California, United States, 92351
San Diego, California, United States, 92103
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Florida
Miami, Florida, United States, 33101
Pensacola, Florida, United States, 32504
United States, Illinois
Chicago, Illinois, United States, 60614
Park Ridge, Illinois, United States, 60068
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
Shreveport, Louisiana, United States, 71130
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
Kansas City, Missouri, United States, 64108
United States, New York
New York, New York, United States, 10032
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Texas
Temple, Texas, United States, 76508
Australia
Brisbane, Australia
Belgium
Antwerpen, Belgium, B-2020
Brussels, Belgium, B-1090
Gent, Belgium, B-9000
France
Paris, France, 75674
Germany
Aachen, Germany, D-52074
Osnabruck, Germany, D-49074
Italy
Brescia, Italy, 25123
Naples, Italy, 80131
Roma, Italy, 00161
Poland
Krakow, Poland, 30-663
Lodz, Poland, 91-738
Lublin, Poland
Warszaw, Poland, 04-730
Switzerland
Zurich, Switzerland, 8032
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
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014