Trials / Completed
CompletedNCT00259012
Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD
A Multicenter, Randomized, Open Label, Single and Multiple Dose Study of the Pharmacokinetics and Pharmacodynamics of 2 Dose Levels of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged 1 Through 11 Months With Presumed GERD
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 1 Month – 11 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pantoprazole sodium enteric-coated spheroid suspension | pediatric suspension taken daily x 7 days |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2008-03-01
- Completion
- 2008-03-01
- First posted
- 2005-11-28
- Last updated
- 2010-05-07
- Results posted
- 2010-05-07
Locations
31 sites across 8 countries: United States, Australia, Belgium, France, Germany, Italy, Poland, Switzerland
Source: ClinicalTrials.gov record NCT00259012. Inclusion in this directory is not an endorsement.