An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242736
• Other study ID #: D9612L00083
• Status: Completed
• Phase: Phase 4
• First received: October 19, 2005
• Last updated: March 5, 2009
• Start date: October 2005
• Est. completion date: January 2006

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Drug:
• Esomeprazole

Locations

Country	Name	City	State
United States	Research Site	Alabaster	Alabama
United States	Research Site	Anaheim	California
United States	Research Site	Arlington Heights	Illinois
United States	Research Site	Austin	Texas
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Christiansburg	Virginia
United States	Research Site	Elkin	North Carolina
United States	Research Site	Hollywood	Maryland
United States	Research Site	Houston	Texas
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Mobile	Alabama
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Norfolk	Virginia
United States	Research Site	North Little Rock	Arkansas
United States	Research Site	Ocoee	Florida
United States	Research Site	Ogden	Utah
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange	California
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Tampa	Florida
United States	Research Site	Torrance	California
United States	Research Site	Tucson	Arizona
United States	Research Site	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE
Secondary	The outcome variables will be resolution of acid regurgitation, dysphagia, and epigastric pain symptoms after 2 and 4 weeks of treatment.
Secondary	The outcome variable will be the resolution of heartburn after 2 weeks of treatment.
Secondary	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.
Secondary	The outcome variable used for this objective will be the percentage of endoscoped patients with EE (LA Classification Grades A-D) at baseline.
Secondary	Safety variables that will be measured and tabulated include adverse events, laboratory evaluations, physical exams, and vital signs.