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Study Evaluating Pantoprazole in Children with GERD - Article


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Pantoprazole

Protonix 



Clinical Trial: Study Evaluating Pantoprazole in Children with GERD

This study is currently recruiting patients.
Verified by Wyeth August 2005

Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00141817

Purpose

The purpose of this study is to characterize the PK profile, safety and tolerability of single and multiple doses of pantoprazole in children aged 1 through 11 years with endoscopically proven GERD.
Condition Intervention Phase
Gastroesophageal Reflux
  Drug: Pantoprazole for approximately 9 weeks.
 Phase I

MedlinePlus related topics:  Gastroesophageal Reflux/Hiatal Hernia

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study

Official Title: A Multicenter, Randomized, Open Label, Single, and Multiple Dose Study of the Safety and Pharmacokinetics of 2 Dose Levels of Pantoprazole Sodium in Children Aged 1 Through 11 Years with Endoscopically Proven GERD.

Further Study Details: 
Primary Outcomes: Characterization of the PK profile of single and multiple doses of pantoprazole.
Secondary Outcomes: Assessment of safety and tolerability of pantoprazole and assessment of growth parameters
Expected Total Enrollment:  30

Study start: August 2005

Eligibility

Ages Eligible for Study:  1 Year   -   11 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Endoscopically proven GERD diagnosed within 6 months before study entry.
  • Weight must be equal to or over 8.3 kg; for subjects 6 years or greater, weight must be equal to or under 25 kg

Exclusion Criteria:

  • History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption, Eosinophilic esophagitis
  • Subjects 6-11 years old unable to swallow tablets

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00141817

Trial Manager       clinicaltrialinfo@wyeth.com

California
      San Diego,  California,  92103,  United States; Recruiting
  see Central Contact 

District of Columbia
      Washington,  District of Columbia,  20010,  United States; Recruiting
  see Central Contact 

Florida
      Gainesville,  Florida,  32610,  United States; Recruiting
  see Central Contact 

Illinois
      Park Ridge,  Illinois,  60068,  United States; Recruiting
  see Central Contact 

Indiana
      Indianapolis,  Indiana,  46202,  United States; Recruiting
  see Central Contact 

Kentucky
      Louisville,  Kentucky,  40202,  United States; Recruiting
  see Central Contact 

Massachusetts
      Brockton,  Massachusetts,  02302,  United States; Recruiting
  see Central Contact 

      Boston,  Massachusetts,  02115,  United States; Recruiting
  see Central Contact 

      Boston,  Massachusetts,  02114,  United States; Recruiting
  see Central Contact 

Michigan
      Detroit,  Michigan,  48201,  United States; Recruiting
  see Central Contact 

Mississippi
      Jackson,  Mississippi,  39216,  United States; Recruiting
  see Central Contact 

Missouri
      Kansas City,  Missouri,  64108,  United States; Recruiting
  see Central Contact 

New York
      New York,  New York,  10032,  United States; Recruiting
  see Central Contact 

Texas
      Temple,  Texas,  76508,  United States; Recruiting
  see Central Contact 

Utah
      Salt Lake City,  Utah,  84113,  United States; Recruiting
  see Central Contact 

Wisconsin
      Milwaukee,  Wisconsin,  53226,  United States; Recruiting
  see Central Contact 

Study chairs or principal investigators

Medical Monitor,  Study Director,  Wyeth Research   

More Information

Study ID Numbers:  3001B3-334
Last Updated:  September 1, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00141817
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06


Source: ClinicalTrials.gov
Cache Date: September 7, 2005

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Page Updated: September 6, 2005
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