Efficacy of Esomeprazole in Patients With Frequent Heartburn
Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heartburn
Intervention: Esomeprazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s): Tore Lind, MD, Study Director, Affiliation: AstraZeneca
Summary
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment
of frequent heartburn
Clinical Details
Official title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Secondary outcome: Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment PeriodComparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and non-pregnant ,non-lactating females 18 years or older
- Experience heartburn at least 2 days a week
- Having heartburn that has responded to heartburn medication
- Must discontinue any current heartburn medications
Exclusion Criteria:
- Having a history of erosive esophagitis verified by endoscopy
- Having a history of GERD which was diagnosed by a physician
- Inability to take study medication or complete the study and all study procedures
- Subjects that have required more than one 14-day course of PPI treatment within the
past 4 months
Locations and Contacts
Research site, Mobile, Alabama, United States
Research site, San Francisco, California, United States
Research site, Westlake Village, California, United States
Research site, Lexington, Kentucky, United States
Research site, Rochester, New York, United States
Research site, Dakota Dunes, South Dakota, United States
Research site, Nashville, Tennessee, United States
Research site, Austin, Texas, United States
Research site, San Angelo, Texas, United States
Research site, West Jordan, Utah, United States
Additional Information
Starting date: August 2011
Last updated: March 1, 2013
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