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Efficacy of Esomeprazole in Patients With Frequent Heartburn (NEXT1)

Primary Purpose

Heartburn

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heartburn focused on measuring Heartburn

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site
  • Research site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Esomeprazole 20 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment

Secondary Outcome Measures

Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.
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
The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
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.

Full Information

First Posted
June 1, 2011
Last Updated
February 12, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01370525
Brief Title
Efficacy of Esomeprazole in Patients With Frequent Heartburn
Acronym
NEXT1
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn
Keywords
Heartburn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esomeprazole 20 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Primary Outcome Measure Information:
Title
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time Frame
From randomisation to day 14
Title
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time Frame
From randomization to day 14
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Description
Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.
Time Frame
From randomisation to day 14
Title
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
Description
The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Time Frame
From randomisation to the day 14
Title
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
Description
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.
Time Frame
From randomisation to day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore Lind, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Research site
City
Seminole
State/Province
Florida
Country
United States
Facility Name
Research site
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Research site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research site
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Research site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Research site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Research site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research site
City
Mt Pleasant
State/Province
South Carolina
Country
United States
Facility Name
Research site
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31297231
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.
Results Reference
derived
PubMed Identifier
29788903
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.
Results Reference
derived
PubMed Identifier
27331882
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.
Results Reference
derived
PubMed Identifier
25141241
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.
Results Reference
derived

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Efficacy of Esomeprazole in Patients With Frequent Heartburn

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