The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease...
Date First Received: August 8, 2006
Last Updated: February 4, 2008
Verified by: Wyeth, February 2008
Clinical Trial Phase: Phase 3 | Start Date: July 2006
Overall Status: Completed
Estimated Enrollment: 56
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”
Condition Keyword(s):
Intervention(s):
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: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study
Intervention(s) in this Clinical Trial
- Drug: pantoprazole
Outcome Measures for this Clinical Trial
Primary Measures
- To determine whether or not consistent drug levels can be achieved in neonates and preterm infants with presumed GERD receiving oral doses of pantoprazole.
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 Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
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
Clinical Trials Authorship and Review
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