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Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

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NCT00300755

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Mobile, Alabama, 36604 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
1-5 year
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Ability to undergo endoscopy with required biopsy

- Ages 1 through 5 years

- Endoscopically confirmed GERD by positive endoscopic evidence of reflux related
esophagitis or positive histologic evidence of esophagitis consistent with GERD Other
inclusions apply.

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

- History or presence of upper gastrointestinal anatomic or motor disorders

- Known current or active cow`s milk allergy

- Malignancy

- Other exclusions apply.

NCT00300755
Pfizer
Completed
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)

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Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
A Multicenter, Randomized, Double-Blind Study of the Clinical Outcomes, Safety and Tolerability of Multiple Doses of Pantoprazole Sodium Enteric-Coated Spheroids in Children Ages 1 to 5 With Endoscopically Proven Symptomatic Gastroesophageal Reflux Disease (GERD)
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Gastroesophageal Reflux
Drug: pantoprazole sodium enteric-coated spheroid
pediatric spheroids taken daily x 8 weeks
  • Active Comparator: 1
    Arm 1- Low Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
  • Active Comparator: 2
    Arm 2- Medium Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
  • Active Comparator: 3
    Arm 3- High Dose pantoprazole
    Intervention: Drug: pantoprazole sodium enteric-coated spheroid
Baker R, Tsou VM, Tung J, Baker SS, Li H, Wang W, Rath N, Maguire MK, Comer GM. Clinical results from a randomized, double-blind, dose-ranging study of pantoprazole in children aged 1 through 5 years with symptomatic histologic or erosive esophagitis. Clin Pediatr (Phila). 2010 Sep;49(9):852-65. doi: 10.1177/0009922810369253. Epub 2010 Jun 3.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ability to undergo endoscopy with required biopsy
  • Ages 1 through 5 years
  • Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.

Exclusion Criteria:

  • History or presence of upper gastrointestinal anatomic or motor disorders
  • Known current or active cow`s milk allergy
  • Malignancy
  • Other exclusions apply.
Sexes Eligible for Study: All
1 Year to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00300755
3001B3-328
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
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

FOR MORE INFORMATION

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