- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01370538
Efficacy of Esomeprazole in Patients With Frequent Heartburn (NEXT2)
March 1, 2013 updated by: AstraZeneca
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
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn
Study Overview
Study Type
Interventional
Enrollment (Actual)
341
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Mobile, Alabama, United States
- Research Site
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California
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San Francisco, California, United States
- Research Site
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Westlake Village, California, United States
- Research Site
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Kentucky
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Lexington, Kentucky, United States
- Research Site
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New York
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Rochester, New York, United States
- Research Site
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South Dakota
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Dakota Dunes, South Dakota, United States
- Research Site
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Tennessee
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Nashville, Tennessee, United States
- Research Site
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Texas
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Austin, Texas, United States
- Research Site
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San Angelo, Texas, United States
- Research Site
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Utah
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West Jordan, Utah, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
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Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
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EXPERIMENTAL: Esomeprazole 20 mg
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Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time Frame: From randomisation to day 14
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From randomisation to day 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Time Frame: From randomisation to the day 14
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Treatment period is considered to be both weeks 1 and 2 between V3 and V4.
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From randomisation to the day 14
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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
Time Frame: From randomisation to day 14
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The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
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From randomisation to day 14
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Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
Time Frame: From randomisation to day 14
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There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6).
For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period.
However, for subjects reporting anything less than 14 days the two will not be identical.
For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.
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From randomisation to day 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ACTUAL)
October 1, 2011
Study Completion (ACTUAL)
October 1, 2011
Study Registration Dates
First Submitted
June 1, 2011
First Submitted That Met QC Criteria
June 9, 2011
First Posted (ESTIMATE)
June 10, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
April 11, 2013
Last Update Submitted That Met QC Criteria
March 1, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D961RC00002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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