Efficacy of Esomeprazole in Patients With Frequent Heartburn
NEXT2
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
1 other identifier
interventional
341
1 country
10
Brief Summary
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2011
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 10, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
April 11, 2013
CompletedApril 11, 2013
March 1, 2013
2 months
June 1, 2011
October 19, 2012
March 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
From randomisation to day 14
Secondary Outcomes (3)
Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
From randomisation to the day 14
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
From randomisation to day 14
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
From randomisation to day 14
Study Arms (2)
Esomeprazole 20 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (10)
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
Related Publications (4)
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.
PMID: 31297231DERIVEDPeura 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.
PMID: 29788903DERIVEDPeura 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.
PMID: 27331882DERIVEDPeura 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.
PMID: 25141241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tore Lind, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2011
First Posted
June 10, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
April 11, 2013
Results First Posted
April 11, 2013
Record last verified: 2013-03