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...
Date First Received: November 23, 2005
Last Updated: July 22, 2008
Verified by: Wyeth, July 2008
Clinical Trial Phase: Phase 3 | Start Date: November 2005
Overall Status: Completed
Estimated Enrollment: 92
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: pantoprazole sodium enteric-coated spheroid suspension
- pediatric suspension taken daily x 7 days - 333; pediatric suspension taken daily x 6 weeks - 335
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Arm 1- Low Dose pantoprazole
- Active Comparator: 2
- Arm 2- active drug - pantoprazole
Outcome Measures for this Clinical Trial
Primary Measures
- Characterization of PK and PD profile of single and multiple doses of pantoprazole
- Time Frame: 7 days
Safety Issue?: No
- Time Frame: 7 days
Secondary Measures
- Assessment of safety and tolerability of pantoprazole
- Time Frame: 6 weeks
Safety Issue?: Yes
- Time Frame: 6 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Month
Maximum Age for this Clinical Trial: 11 Months
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259012
Study ID Number: 3001B3-333, 3001B3-335
ClinicalTrials.gov Identifier: NCT00259012
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
