Trials / Completed
CompletedNCT00362609
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
A Multicenter, Open-Label, PK, PD and Safety Study of Pantoprazole Delayed-Release Granules Administered as a Suspension in Neonates and Preterm Infants With a Clinical Diagnosis of GERD
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 1 Day – 28 Days
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pantoprazole |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2007-12-01
- Completion
- 2007-12-01
- First posted
- 2006-08-10
- Last updated
- 2010-05-14
- Results posted
- 2010-05-14
Locations
71 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, South Africa, Switzerland
Source: ClinicalTrials.gov record NCT00362609. Inclusion in this directory is not an endorsement.