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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00259012 |
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Date of registration:
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23/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
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Scientific title:
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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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Date of first enrolment:
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November 2005 |
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Target sample size:
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67 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00259012 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belgium
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France
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Germany
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Italy
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Poland
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Switzerland
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United States
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Australia, medinfo@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Poland, WPWZMED@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, medinfoDEU@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Belgium, trials-BEL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Switzerland, med@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For France, infomedfrance@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, descresg@wyeth.com |
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Key inclusion & exclusion criteria
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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
Age minimum:
1 Month
Age maximum:
11 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastroesophageal Reflux
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Intervention(s)
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Drug: pantoprazole sodium enteric-coated spheroid suspension
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Primary Outcome(s)
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Apparent Oral Clearance (CL/F)
[Time Frame: 1 day]
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Intragastric pH
[Time Frame: 7 days]
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Normalized Area of Esophageal Hydrogen Ion Activity Over Time
[Time Frame: 7 days]
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Normalized Area of Gastric Hydrogen Ion Activity Over Time
[Time Frame: 7 days]
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Area Under the Concentration-time Curve (AUC)
[Time Frame: 1 day]
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Median Intraesophageal pH
[Time Frame: 7 days]
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Median Intragastric pH
[Time Frame: 7 days]
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Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration
[Time Frame: 7 days]
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Mean Intraesophageal pH
[Time Frame: 7 days]
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Disposition Half-life
[Time Frame: 1 day]
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Percentage of Time That Intraesophageal pH Was <4
[Time Frame: 7 days]
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Time to Peak Concentration (Tmax) Profile
[Time Frame: 1 day]
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Percentage of Time Intragastric pH Was >4
[Time Frame: 7 days]
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Peak Concentration (Cmax)
[Time Frame: 1 day]
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Secondary ID(s)
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3001B3-333, 3001B3-335
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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