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Study Evaluating Pantoprazole in Children With GERD

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NCT00141817

Last updated on May 11, 2018
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FOR MORE INFORMATION
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 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- History of GI disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption,
Eosinophilic esophagitis

- Subjects 6-11 years old unable to swallow tablets

NCT00141817
Pfizer
Completed
Study Evaluating Pantoprazole in Children With GERD

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Study Evaluating Pantoprazole in Children With GERD
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastroesophageal Reflux
Drug: pantoprazole for approximately 9 weeks.
Not Provided
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
41
November 2007
November 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Year to 11 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00141817
3001B3-334
B1791059
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
November 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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