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)...
Date First Received: August 21, 2006
Last Updated: December 7, 2007
Verified by: Wyeth, December 2007
Clinical Trial Phase: Phase 3 | Start Date: January 2007
Overall Status: Completed
Estimated Enrollment: 20
Brief Summary
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.”
Condition Keyword(s):
Intervention(s):
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).
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study
Intervention(s) in this Clinical Trial
- Drug: pantoprazole
Outcome Measures for this Clinical Trial
Primary Measures
- Characterization of the PK profile of single and multiple doses of pantoprazole.
Secondary Measures
- Assess the safety and tolerability of pantoprazole.
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: 16 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Wyeth
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Wyeth
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367614
Study ID Number: 3001A3-337
ClinicalTrials.gov Identifier: NCT00367614
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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