Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease...
Brief Summary
Official Title: “A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD”
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: December 2007
Intervention(s) in this Clinical Trial
- Drug: pantoprazole
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: Low dose
- Active Comparator: High dose
Outcome Measures for this Clinical Trial
Primary Measures
- Variance of Oral Bioavailability
- Time Frame: 1 day
Safety Issue?: No
- Time Frame: 1 day
Secondary Measures
- Area Under the Concentration-time Curve (AUC)
- Time Frame: Baseline to 24 hours post dose on Day 1
Safety Issue?: No
- Time Frame: Baseline to 24 hours post dose on Day 1
- Apparent Oral Clearance (Cl/F)
- Time Frame: 1 day
Safety Issue?: No
- Time Frame: 1 day
- Half Life
- Time Frame: 1 day
Safety Issue?: No
- Time Frame: 1 day
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Hospitalized patients
- Presumed diagnosis of GERD
- Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks
Exclusion Criteria:
- cardiovascular instability
- clinically significant laboratory abnormalities
- use of warfarin, carbamazepine, phenytoin, or rifampin
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 28 Days
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/NCT00362609
Study ID Number: 3001B3-331, 3001B3-335
ClinicalTrials.gov Identifier: NCT00362609
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00362609
