Clinical trial
Phase 3/Safety & Efficacy of Esomeprazole in Infants
NCT00468559 · AstraZeneca, Industry · Completed
Key facts
| NCT number | NCT00468559 |
|---|---|
| Title | Phase 3/Safety & Efficacy of Esomeprazole in Infants |
| Official title | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Treatment-withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive |
| Lead sponsor | AstraZeneca, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Gastroesophageal Reflux Disease (GERD) |
| Intervention type | Drug |
| Interventions | Open Label Run In Esomeprazole, Double Blind Esomeprazole, Double Blind Placebo |
| Enrollment | 98 |
| Start date | Apr 1, 2007 |
| Primary completion | Jun 1, 2008 |
| Completion | Jun 1, 2008 |
| First posted | May 2, 2007 |
| Last update posted | Jun 2, 2014 |
| Countries | France, Germany, Poland, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: