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

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NCT00259012

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Study Location
Little Rock, Arkansas, 72205, United States
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Contact
1-800-718-1021
[email protected]
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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

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Advanced Information
Descriptive Information
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
  • Active Comparator: Low dose
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension
  • Active Comparator: High dose
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid suspension
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
 (submitted: April 19, 2010)		67
Original Enrollment  ICMJE
 (submitted: November 23, 2005)		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor France, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Poland, [email protected]
Principal Investigator:Trial ManagerFor Switzerland, [email protected]
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