Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

Study Overview
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Brief Summary
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To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.

Official Title
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A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use

Conditions
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Prevention

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent before starting the study-related procedures and examinations Patients who have the history of gastric and/or duodenal ulcer. A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period. Exclusion Criteria: Having gastric or duodenal ulcer (except for ulcer scar). History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.

Ages Eligible for Study
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Minimum Age: 20 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 20mg<br>Esomeprazole 20mg once daily oral | Drug: Esomeprazole<br>* 20mg, capsule, 72 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo once daily oral | Drug: Placebo<br>* Placebo, capsule, 72 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. | Assessments for occurrence of gastric and/or duodenal ulcers were performed every 12 weeks after randomisation. The numbers of participants with recurrence of gastric and/or duodeal ulcers were analysed every 12 weeks up to 48 weeks. | From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48 | Modified Lanza scale attributes the degree of gastric mucosal lesion, graded on a 5 point scale (0=No hemorrhage, no erosion, 1=One hemorrhage or one erosions, 2=2-10 hemorrhages or erosions, 3=11-25 hemorrhages or erosions, 4=More than 25 hemorrhages or erosions, or ulcer). Higher scores indicate greater severity of gastric mucosal lesion. | Up to 48 weeks (Baseline to last measurement) | 
| Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48. | Endoscopy was conducted at 12, 24, 36 and 48 weeks after randomisation. At the endoscopy, participants was evaluated whether they have reflux esophagitis or not. | 12, 24, 36 and 48 weeks | 
| Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48 | The severity of epigastric pain at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened. | Up to 48 weeks (Baseline to last measurement) | 
| Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48. | The severity of heartburn at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened. | Up to 48 weeks (Baseline to last measurement) | 
| Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48 | The severity of anorexia at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened. | Up to 48 weeks (Baseline to last measurement) | 
| Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week | The severity of abdomen enlarged feeling at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened. | Up to 48 weeks (Baseline to last measurement) | 
| Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48 | The severity of Nausea and/or Vomiting at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened. | Up to 48 weeks (Baseline to last measurement) | 
| Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48 | The severity of Discomfort in the stomach at baseline and the last measurement up to 48 weeks was obtained (None, Mild, Moderate, Severe). If the value at the last was better in a participant, the participant was categorized into Improved. If the value was same, categorised into Unchanged. If the value was worsened, categorise into Worsened. | Up to 48 weeks (Baseline to last measurement) | 
| Number of Participants With Adverse Events | Participants who had at least adverse events (AE) which occurred after receiving study drug were counted. | Up to 70 weeks at the longest | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric ulcer, Duodenal ulcer, Low-dose aspirin