Efficacy of Esomeprazole in Patients With Frequent Heartburn
NCT ID: NCT01370538
Last Updated: 2013-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
341 participants
INTERVENTIONAL
2011-08-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Esomeprazole 20 mg
Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Placebo
Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Interventions
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Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tore Lind, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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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
Countries
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References
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Peura D, Le Moigne A, Wassel H, Pollack C. Analysis of the symptom response to esomeprazole 20 mg over days 1-4 of a 14-day course of treatment for frequent heartburn: results of two randomised controlled trials. BMJ Open Gastroenterol. 2019 Jun 21;6(1):e000278. doi: 10.1136/bmjgast-2019-000278. eCollection 2019.
Peura DA, Le Moigne A, Wassel H, Pollack C. Sustained efficacy following resolution of frequent heartburn with an over-the-counter regimen of esomeprazole 20 mg or placebo for 14 days: two randomized trials. BMC Gastroenterol. 2018 May 22;18(1):69. doi: 10.1186/s12876-018-0790-2.
Peura D, Le Moigne A, Pollack C, Nagy P, Lind T. A 14-day regimen of esomeprazole 20 mg/day for frequent heartburn: durability of effects, symptomatic rebound, and treatment satisfaction. Postgrad Med. 2016 Aug;128(6):577-83. doi: 10.1080/00325481.2016.1203236. Epub 2016 Jul 4.
Peura DA, Traxler B, Kocun C, Lind T. Esomeprazole treatment of frequent heartburn: two randomized, double-blind, placebo-controlled trials. Postgrad Med. 2014 Jul;126(4):33-41. doi: 10.3810/pgm.2014.07.2781.
Other Identifiers
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D961RC00002
Identifier Type: -
Identifier Source: org_study_id
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