The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
- Greater than 44 weeks beyond neonatal period but less than 12 months
- Presumptive diagnosis of GERD
- Weight greater than 2.5 kg but less than 15 kg
- History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal
fistula, GI malabsorption
- Clinically significant medical or surgical abnormalities
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 Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD | ||||||||||||||||||||||||
| Official Title ICMJE | A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD | ||||||||||||||||||||||||
| Brief Summary | The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months. | ||||||||||||||||||||||||
| 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 sodium enteric-coated spheroid suspension pediatric suspension taken daily x 7 days | ||||||||||||||||||||||||
| Study Arms ICMJE |
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| Publications * | Tammara BK, Sullivan JE, Adcock KG, Kierkus J, Giblin J, Rath N, Meng X, Maguire MK, Comer GM, Ward RM. Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. Clin Pharmacokinet. 2011 Aug;50(8):541-50. doi: 10.2165/11591900-000000000-00000. | ||||||||||||||||||||||||
| * 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 | 67 | ||||||||||||||||||||||||
| Original Enrollment ICMJE | 72 | ||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | March 2008 | ||||||||||||||||||||||||
| Actual Primary Completion Date | March 2008 (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 | 1 Month to 11 Months (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, France, Germany, Italy, Poland, Switzerland, United States | ||||||||||||||||||||||||
| Removed Location Countries | |||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number ICMJE | NCT00259012 | ||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 3001B3-333, 3001B3-335 | ||||||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||||||
| 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 | Nycomed | ||||||||||||||||||||||||
| 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
