Trials / Completed
CompletedNCT00427635
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 1 Month
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esomeprazole |
Timeline
- Start date
- 2006-10-01
- Completion
- 2009-04-01
- First posted
- 2007-01-29
- Last updated
- 2010-12-20
- Results posted
- 2010-05-19
Locations
3 sites across 3 countries: Australia, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT00427635. Inclusion in this directory is not an endorsement.