Acid-Associated Heartburn Symptoms and Dose of Esomeprazole
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heartburn
Intervention: Esomeprazole magnesium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Nexium Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Summary
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.
Clinical Details
Official title: A 4-Week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium
Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Relief of heartburn during the 4th week of treatmentCumulative 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Research Site, Ponce, Puerto Rico
Research Site, Tucson, Arizona, United States
Research Site, San Diego, California, United States
Research Site, Orange, California, United States
Research Site, Anaheim, California, United States
Research Site, Washington, District of Columbia, United States
Research Site, DeLand, Florida, United States
Research Site, Zephyrhills, Florida, United States
Research Site, Miami, Florida, United States
Research Site, Tampa, Florida, United States
Research Site, New Smyrna Beach, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, New Orleans, Louisiana, United States
Research Site, Hollywood, Maryland, United States
Research Site, Annapolis, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Attleboro, Massachusetts, United States
Research Site, Vineland, New Jersey, United States
Research Site, Hackensack, New Jersey, United States
Research Site, Rochester, New York, United States
Research Site, Asheville, North Carolina, United States
Research Site, Elkin, North Carolina, United States
Research Site, Guthrie, Oklahoma, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Christiansburg, Virginia, United States
Additional Information
Starting date: November 2004
Last updated: June 21, 2006
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