An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)
1 other identifier
interventional
350
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2005
Shorter than P25 for phase_4
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 19, 2005
CompletedFirst Posted
Study publicly available on registry
October 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedMarch 6, 2009
March 1, 2009
October 19, 2005
March 5, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE
Secondary Outcomes (5)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Symptoms of GERD as defined in this protocol: Heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the Screening visit (Visit 1) and, on average, at least 2 times per week over the past 3 months.
- Male or female, 18 to 70 years old, inclusive.
- Non-pregnant, non-lactating female patients. Female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. Females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.
- Negative urine pregnancy test for females of childbearing potential.
- Willingness to adhere to all protocol requirements.
You may not qualify if:
- Previous enrollment in the present study.
- Significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study.
- Use of a PPI, including PRILOSEC OTC®, within 21 days of Screening (Visit 1) or at anytime during the study (Visit 1 through Visit 4).
- Daily therapy with an H2 RA within 14 days of Screening (Visit 1): eg, ranitidine (ZANTAC®), cimetidine (TAGAMET®), nizatidine (AXID®), famotidine (PEPCID®) (occasional use; ie, less than daily, is permitted).
- Use of H2 RAs at any frequency are prohibited throughout the entire study (Visit 1 through Visit 4).
- A history of gastric or esophageal surgery (including, but not limited to, Nissen fundoplication and bariatric surgery), except for simple closure of a perforated ulcer or procedures that would not affect the study as determined by the Clinical Study Team physician at AstraZeneca.
- Clinically significant gastrointestinal (GI) bleeding (eg, melena, frank hematochezia) within 3 days of Screening (Visit 1) or noted at the time of baseline EGD.
- Non-acid related etiologies of esophagitis (eg, pill-induced, caustic ingestion or eosinophilic esophagitis).
- Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (25)
Research Site
Alabaster, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
North Little Rock, Arkansas, United States
Research Site
Anaheim, California, United States
Research Site
Orange, California, United States
Research Site
Torrance, California, United States
Research Site
Miami, Florida, United States
Research Site
Ocoee, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Zephyrhills, Florida, United States
Research Site
Arlington Heights, Illinois, United States
Research Site
New Orleans, Louisiana, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Hollywood, Maryland, United States
Research Site
Elkin, North Carolina, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Austin, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Ogden, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Christiansburg, Virginia, United States
Research Site
Norfolk, Virginia, United States
Related Publications (1)
Orlando RC, Monyak JT, Silberg DG. Predictors of heartburn resolution and erosive esophagitis in patients with GERD. Curr Med Res Opin. 2009 Sep;25(9):2091-102. doi: 10.1185/03007990903080931.
PMID: 19601705DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Sciences Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 19, 2005
First Posted
October 21, 2005
Study Start
October 1, 2005
Study Completion
January 1, 2006
Last Updated
March 6, 2009
Record last verified: 2009-03