Study Evaluating Pantoprazole in Adolescents With GERD
Phase 3
Completed
- Conditions
- Gastroesophageal Reflux
- Registration Number
- NCT00367614
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Characterization of the PK profile of single and multiple doses of pantoprazole.
- Secondary Outcome Measures
Name Time Method Assess the safety and tolerability of pantoprazole.