The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
- 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
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | |||||||||||||||||||||||||||||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
