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NCT00367614 Clinical Trial

Study Evaluating Pantoprazole in Adolescents With GERD

Gastroesophageal Reflux Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00367614
Other study ID # 3001A3-337
Secondary ID
Status Completed
Phase Phase 3
First received August 21, 2006
Last updated December 7, 2007
Start date January 2007
Est. completion date August 2007

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 16 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pantoprazole

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Characterization of the PK profile of single and multiple doses of pantoprazole.
Secondary Assess the safety and tolerability of pantoprazole.
See also
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