Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium

This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.

Study Overview

• Status: Completed
• Conditions: Heartburn
• Intervention / Treatment: Drug: Esomeprazole magnesium (Nexium)

• Study Type: Interventional
• Enrollment: 330
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Ponce, Puerto Rico
    • Research Site
• United States
  • Arizona
    • Tucson, Arizona, United States
      • Research Site
  • California
    • Anaheim, California, United States
      • Research Site
    • Orange, California, United States
      • Research Site
    • San Diego, California, United States
      • Research Site
  • District of Columbia
    • Washington, District of Columbia, United States
      • Research Site
  • Florida
    • DeLand, Florida, United States
      • Research Site
    • Miami, Florida, United States
      • Research Site
    • New Smyrna Beach, Florida, United States
      • Research Site
    • Tampa, Florida, United States
      • Research Site
    • Zephyrhills, Florida, United States
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States
      • Research Site
  • Illinois
    • Chicago, Illinois, United States
      • Research Site
  • Louisiana
    • New Orleans, Louisiana, United States
      • Research Site
  • Maryland
    • Annapolis, Maryland, United States
      • Research Site
    • Baltimore, Maryland, United States
      • Research Site
    • Hollywood, Maryland, United States
      • Research Site
  • Massachusetts
    • Attleboro, Massachusetts, United States
      • Research Site
  • New Jersey
    • Hackensack, New Jersey, United States
      • Research Site
    • Vineland, New Jersey, United States
      • Research Site
  • New York
    • Rochester, New York, United States
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States
      • Research Site
    • Elkin, North Carolina, United States
      • Research Site
  • Oklahoma
    • Guthrie, Oklahoma, United States
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Research Site
  • Tennessee
    • Knoxville, Tennessee, United States
      • Research Site
  • Virginia
    • Christiansburg, Virginia, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
• A history of heartburn for at least 6 months
• A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
• A positive esophageal acid perfusion test
• At least 3 days of 'moderate' severity heartburn over the previous 7 days
• No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization

Exclusion Criteria:

• A history of gastric or esophageal surgery
• H. pylori positive
• A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
• Currently taking higher than the standard approved proton pump inhibitor doses
• Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".

Secondary Outcome Measures

Outcome Measure
Relief of heartburn during the 4th week of treatment
Cumulative daily sustained resolution rate through 4 weeks of treatment
Time to first day of the first 7-day period of sustained resolution of heartburn
Time to the first day of the first 7-day period of relief of heartburn
Percentage of subject-reported heartburn-free days through 4 weeks of treatment
Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Nexium Medical Science Director, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Study Completion (Actual): July 1, 2005

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): November 19, 2010
• Last Update Submitted That Met QC Criteria: November 18, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: D9612L00064