Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

Study Overview
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Brief Summary
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The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Official Title
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A Randomized, Double-blind, Parallel-group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 or 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)

Conditions
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Gastric Ulcer, Duodenal Ulcer

Intervention / Treatment
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* Drug: Esomeprazole 40 mg
* Drug: Esomeprazole 20 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e): Aged ≥65 years. Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s). Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization). Aged ≥60 years and with stable coronary artery disease. Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy. Exclusion Criteria: Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD). Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline History of peptic ulcer complications such as clinically significant bleeding and/or perforation.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esomeprazole 40 mg<br>Esomeprazole 40 mg | Drug: Esomeprazole 40 mg<br>* Esomeprazole 40 mg once daily<br>|
| Experimental: Esomeprazole 20 mg<br>Esomeprazole 20 mg | Drug: Esomeprazole 20 mg<br>* Esomeprazole 20 mg once daily<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s). | The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal. | During 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experienced the Occurence of Gastric Ulcer. | The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal. | During 26 weeks | 
| Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer. | The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal. | During 26 weeks | 
| Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit. | RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence. | RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal. | 
| Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit. | RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence. | RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal. | 
| Number of Participants With Gastric and/or Duodenal Erosions. |  | The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peptic ulcer, low-dose ASA