Status:
COMPLETED
An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
AstraZeneca
Conditions:
GERD
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00242736
Start Date
October 1 2005
End Date
January 1 2006
Last Update
March 6 2009
Active Locations (25)
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1
Research Site
Alabaster, Alabama, United States
2
Research Site
Mobile, Alabama, United States
3
Research Site
Tucson, Arizona, United States
4
Research Site
North Little Rock, Arkansas, United States