Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborator:
Nycomed: A Takeda Company
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
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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
Show 31 Study Locations
Show 31 Study LocationsSponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Nycomed: A Takeda Company
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 May 16, 2013