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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Esomeprazole 40 mg
* Procedure: Physical Exam
* Other: Quality of Life Questionnaires
* Procedure: pregnancy test, if applicable


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nexium 40 mgs<br> | Drug: Esomeprazole 40 mg<br>* Once a day<br>* Other names: Nexium;Procedure: Physical Exam<br>* every visit<br>Other: Quality of Life Questionnaires<br>* every visit<br>Procedure: pregnancy test, if applicable<br>* as needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Baseline and 4 weeks | 
| 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). | At Baseline and 8 weeks | 
| 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). | At Baseline and 4 weeks | 
| 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). | At Baseline and 4 weeks. | 
| 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). | At Baseline and 8 weeks. | 
| 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). | At Baseline and 4 weeks | 
| 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). | At Baseline and 8 weeks | 
| 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). | At Baseline and 8 weeks | 
| 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). | At Baseline and 4 weeks | 
| 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). | At Baseline and 8 weeks | 
| 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). | At Baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heartburn, reflux, proton, pump, inhibitor