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Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

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NCT00259012

Last updated on December 6, 2018
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FOR MORE INFORMATION
Study Location
Little Rock, Arkansas, 72205 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gastroesophageal Reflux
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
1-11 month
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal
fistula, GI malabsorption

- Clinically significant medical or surgical abnormalities

NCT00259012
Pfizer
Completed
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

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Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastroesophageal Reflux
Drug: pantoprazole sodium enteric-coated spheroid suspension
pediatric suspension taken daily x 7 days
  • Active Comparator: Low dose
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension
  • Active Comparator: High dose
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension
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.
 
Completed
67
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
  • Clinically significant medical or surgical abnormalities
Sexes Eligible for Study: All
1 Month to 11 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   France,   Germany,   Italy,   Poland,   Switzerland,   United States
 
 
NCT00259012
3001B3-333, 3001B3-335
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Nycomed
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Australia, [email protected]
Principal Investigator: Trial Manager For Belgium, [email protected]
Principal Investigator: Trial Manager For France, [email protected]
Principal Investigator: Trial Manager For Germany, [email protected]
Principal Investigator: Trial Manager For Italy, [email protected]
Principal Investigator: Trial Manager For Poland, [email protected]
Principal Investigator: Trial Manager For Switzerland, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
April 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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