An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)
NCT ID: NCT00242736
Last Updated: 2009-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
350 participants
INTERVENTIONAL
2005-10-31
2006-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
NCT00206180
Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients
NCT00444275
Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously
NCT00635414
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
NCT05267613
A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
NCT00734097
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Esomeprazole
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
AstraZeneca Nexium Medical Sciences Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D9612L00083
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.