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

Status

Completed

Conditions

Intervention / Treatment

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

    • Alabama
      • Mobile, Alabama, United States
        • Research Site
    • California
      • San Francisco, California, United States
        • Research Site
      • Westlake Village, California, United States
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Research Site
    • New York
      • Rochester, New York, United States
        • Research Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Austin, Texas, United States
        • Research Site
      • San Angelo, Texas, United States
        • Research Site
    • Utah
      • West Jordan, Utah, United States
        • Research Site

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
PLACEBO_COMPARATOR: Placebo
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
EXPERIMENTAL: Esomeprazole 20 mg
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose

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
From randomisation to day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Time Frame: From randomisation to the day 14
Treatment period is considered to be both weeks 1 and 2 between V3 and V4.
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
Time Frame: From randomisation to day 14
The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
From randomisation to day 14
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
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.
From randomisation to day 14

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.

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

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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