Clinical trial NCT01370538: Efficacy of Esomeprazole in Patients With Frequent Heartburn
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heartburn
Keywords: Heartburn
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn


Eligibility 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

Primary outcomes:
measure: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
timeFrame: From randomisation to day 14
Secondary outcomes:
measure: Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
timeFrame: From randomisation to the day 14
measure: Comparison 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
timeFrame: From randomisation to day 14
measure: Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
timeFrame: From randomisation to day 14
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research site
state: Alabama
city: San Francisco
country: United States
facility: Research site
state: California
city: Westlake Village
country: United States
facility: Research site
state: California
city: Lexington
country: United States
facility: Research site
state: Kentucky
city: Rochester
country: United States
facility: Research site
state: New York
city: Dakota Dunes
country: United States
facility: Research site
state: South Dakota
city: Nashville
country: United States
facility: Research site
state: Tennessee
city: Austin
country: United States
facility: Research site
state: Texas
city: San Angelo
country: United States
facility: Research site
state: Texas
city: West Jordan
country: United States
facility: Research site
state: Utah
Study officials:
affiliation: AstraZeneca
name: Tore Lind, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.