Back to resultsA Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI) (NEON)
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Esomeprazole 40 mg
Physical Exam
Quality of Life Questionnaires
pregnancy test, if applicable
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring heartburn, reflux, proton, pump, inhibitor
Eligibility Criteria
Inclusion Criteria:
- Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
- informed consent
- over 18 years of age
Exclusion Criteria:
- Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
- More than 1 other course of PPI treatment in the previous 12 month
- previous use of esomeprazole
- presence of alarm symptoms
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 Type
Experimental
Arm Label
Nexium 40 mgs
Arm Description
Outcomes
Primary Outcome Measures
Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline
Secondary Outcome Measures
Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment
Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.
Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment
Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment
Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.
Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.
Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Frequency of Epigastric Pain After 4 Weeks of Treatment
Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Frequency of Epigastric Pain After 8 Weeks of Treatment
Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe).
Change in Severity of Epigastric Pain After 8 Weeks of Treatment
Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Severity of Epigastric Pain After 4 Weeks of Treatment
Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Severity of Acid Regurgitation After 8 Weeks of Treatment
Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Severity of Acid Regurgitation After 4 Weeks of Treatment
Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00734097
Brief Title
A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
Acronym
NEON
Official Title
An Open Label, Multicentre Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
heartburn, reflux, proton, pump, inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
314 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nexium 40 mgs
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40 mg
Other Intervention Name(s)
Nexium
Intervention Description
Once a day
Intervention Type
Procedure
Intervention Name(s)
Physical Exam
Intervention Description
every visit
Intervention Type
Other
Intervention Name(s)
Quality of Life Questionnaires
Intervention Description
every visit
Intervention Type
Procedure
Intervention Name(s)
pregnancy test, if applicable
Intervention Description
as needed
Primary Outcome Measure Information:
Title
Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
Description
Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline
Time Frame
At Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment
Description
Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.
Time Frame
At Baseline and 4 weeks
Title
Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment
Description
Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 8 weeks
Title
Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment
Description
Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 4 weeks
Title
Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.
Description
Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 4 weeks.
Title
Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.
Description
Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 8 weeks.
Title
Change in Frequency of Epigastric Pain After 4 Weeks of Treatment
Description
Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 4 weeks
Title
Change in Frequency of Epigastric Pain After 8 Weeks of Treatment
Description
Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.
Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe).
Time Frame
At Baseline and 8 weeks
Title
Change in Severity of Epigastric Pain After 8 Weeks of Treatment
Description
Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 8 weeks
Title
Change in Severity of Epigastric Pain After 4 Weeks of Treatment
Description
Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 4 weeks
Title
Change in Severity of Acid Regurgitation After 8 Weeks of Treatment
Description
Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 8 weeks
Title
Change in Severity of Acid Regurgitation After 4 Weeks of Treatment
Description
Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".
Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Time Frame
At Baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
informed consent
over 18 years of age
Exclusion Criteria:
Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
More than 1 other course of PPI treatment in the previous 12 month
previous use of esomeprazole
presence of alarm symptoms
Facility Information:
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Santiago de Chile
Country
Chile
Facility Name
Research Site
City
Temuco
Country
Chile
Facility Name
Research Site
City
Vina del Mar
Country
Chile
Facility Name
Research Site
City
Barranquilla
Country
Colombia
Facility Name
Research Site
City
Bogota
Country
Colombia
Facility Name
Research Site
City
Medellin
Country
Colombia
Facility Name
Research Site
City
Barquisimeto
Country
Venezuela
Facility Name
Research Site
City
Caracas
Country
Venezuela
Facility Name
Research Site
City
San Cristobal
Country
Venezuela
12. IPD Sharing Statement
Learn more about this trial
A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
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