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Study Evaluating Pantoprazole in Adolescents With GERD

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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
12-16 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 12-16 years old

- clinical diagnosis of GERD

- ability to swallow tablets

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

- GI or malabsorption disorders

- chronic use of warfarin

- positive pregnancy test

NCT00367614
Pfizer
Completed
Study Evaluating Pantoprazole in Adolescents With GERD

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Gastroesophageal Reflux Disease
NCT02401035
All Genders
1+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Study Evaluating Pantoprazole in Adolescents With GERD
Official Title  ICMJE A Multicenter, Randomized, Open-Label, Single And Multiple Dose Study Of The Pharmacokinetics And Safety of Two Dose Levels of Pantoprazole Sodium Tablets In Adolescents Aged 12 Through 16 Years With A Clinical Daignosis Of GERD.
Brief SummaryThe purpose of this study is characterize the PK profile of single and multiple doses of pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux
Intervention  ICMJE Drug: pantoprazole
Study Arms  ICMJE Not Provided
Publications *Not Provided


*   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
Estimated Enrollment  ICMJE
 (submitted: August 21, 2006)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 12-16 years old
  • clinical diagnosis of GERD
  • ability to swallow tablets

Exclusion Criteria:

  • GI or malabsorption disorders
  • chronic use of warfarin
  • positive pregnancy test
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00367614
Other Study ID Numbers  ICMJE 3001A3-337
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateDecember 2007

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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