Study Evaluating Pantoprazole in Children With GERD
The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD...
Brief Summary
Official Title: “A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years With Endoscopically Proven GERD”
The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: November 2007
Intervention(s) in this Clinical Trial
- Drug: pantoprazole for approximately 9 weeks.
Outcome Measures for this Clinical Trial
Primary Measures
- Maximum Observed Plasma Concentration (Cmax)
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Safety Issue?: No
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
- Time to Reach Maximum Observed Plasma Concentration (Tmax)
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Safety Issue?: No
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Safety Issue?: No
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Safety Issue?: No
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
- Plasma Decay Half-Life (t1/2)
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Safety Issue?: No
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
- Apparent Oral Clearance (CL/F)
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Safety Issue?: No
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
- Terminal-Phase Volume of Distribution (Vz/F)
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
Safety Issue?: No
- Time Frame: Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose
- Plasma Concentrations After Multiple Doses
- Time Frame: Hours 2 and 4 on Day 7
Safety Issue?: No
- Time Frame: Hours 2 and 4 on Day 7
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Endoscopically proven GERD diagnosed within 6 months before study entry.
- Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg
Exclusion Criteria:
- History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
- Subjects 6-11 years old unable to swallow tablets
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 1 Year
Maximum Age for this Clinical Trial: 11 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00141817
Study ID Number: 3001B3-334
ClinicalTrials.gov Identifier: NCT00141817
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00141817
