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Study Evaluating Pantoprazole in Adolescents With GERD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00367614
First Posted: August 23, 2006
Last Update Posted: December 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
The 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).

Condition Intervention Phase
Gastroesophageal Reflux Drug: pantoprazole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Characterization of the PK profile of single and multiple doses of pantoprazole.

Secondary Outcome Measures:
  • Assess the safety and tolerability of pantoprazole.

Estimated Enrollment: 20
Study Start Date: January 2007
Study Completion Date: August 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367614


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00367614     History of Changes
Other Study ID Numbers: 3001A3-337
First Submitted: August 21, 2006
First Posted: August 23, 2006
Last Update Posted: December 10, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Adolescents
GERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action