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

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

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.

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: Esomeprazole

• Study Type: Interventional
• Enrollment: 350
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The outcome variable will be the percentage of patients with heartburn resolution stratified by the presence or absence of EE

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: October 19, 2005
• First Submitted That Met QC Criteria: October 19, 2005
• First Posted (Estimate): October 21, 2005

Study Record Updates

• Last Update Posted (Estimate): March 6, 2009
• Last Update Submitted That Met QC Criteria: March 5, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: D9612L00083