An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)
|ClinicalTrials.gov Identifier: NCT00242736|
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : March 6, 2009
|Condition or disease||Intervention/treatment||Phase|
|GERD||Drug: Esomeprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2005|
|Study Completion Date :||January 2006|
- The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE
- The outcome variables will be resolution of acid regurgitation, dysphagia, and epigastric pain symptoms after 2 and 4 weeks of treatment.
- The outcome variable will be the resolution of heartburn after 2 weeks of treatment.
- The outcome variables will be the presence or absence of EE at baseline and the resolution of heartburn at the end of the 4-week treatment period.
- The outcome variable used for this objective will be the percentage of endoscoped patients with EE (LA Classification Grades A-D) at baseline.
- Safety variables that will be measured and tabulated include adverse events, laboratory evaluations, physical exams, and vital signs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00242736
Show 25 Study Locations
|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|