Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
NCT00362609
ABOUT THIS STUDY
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- 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
- cardiovascular instability
- clinically significant laboratory abnormalities
- use of warfarin, carbamazepine, phenytoin, or rifampin
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Descriptive Information | |||||||||||||||||||||||||||||||
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Brief Title ICMJE | Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD | ||||||||||||||||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||||||||||||||||
Brief Summary | The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease. | ||||||||||||||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||||||||||||||||||
Condition ICMJE | Gastroesophageal Reflux | ||||||||||||||||||||||||||||||
Intervention ICMJE | Drug: pantoprazole | ||||||||||||||||||||||||||||||
Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||||||||||||||||||
Recruitment Information | |||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||
Actual Enrollment ICMJE | 59 | ||||||||||||||||||||||||||||||
Original Enrollment ICMJE | 44 | ||||||||||||||||||||||||||||||
Actual Study Completion Date ICMJE | December 2007 | ||||||||||||||||||||||||||||||
Actual Primary Completion Date | December 2007 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 28 Days (Child) | ||||||||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, South Africa, Switzerland, United States | ||||||||||||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT00362609 | ||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | 3001B3-331, 3001B3-335 | ||||||||||||||||||||||||||||||
Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||||||||||||||||||||||||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||||||||||||||||||||||||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||||||||
Verification Date | April 2010 | ||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |