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Sponsored by: |
AstraZeneca |
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00242736 |
The purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without EE.
Condition | Intervention | Phase |
GERD |
Drug: Esomeprazole |
Phase IV |
MedlinePlus related topics: | GERD Heartburn |
ChemIDplus related topics: | Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium BaseLine |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD) to Investigate the Relationship Between the Presence of Erosive Esophagitis (EE) at Baseline and Heartburn Resolution After 4 Weeks of Treatment |
Estimated Enrollment: | 350 |
Study Start Date: | October 2005 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).
Show 25 Study Locations |
AstraZeneca |
Study Director: | AstraZeneca Nexium Medical Sciences Director, MD | AstraZeneca |
Study ID Numbers: | D9612L00083 |
First Received: | October 19, 2005 |
Last Updated: | August 15, 2007 |
ClinicalTrials.gov Identifier: | NCT00242736 |
Health Authority: | United States: Food and Drug Administration |
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