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

• Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ] [ Designated as safety issue: No ]
  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.
• Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48. [ Time Frame: 12, 24, 36 and 48 weeks ] [ Designated as safety issue: No ]
  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.
• Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ] [ Designated as safety issue: No ]
  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".
• Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48. [ Time Frame: Up to 48 weeks (Baseline to last measurement) ] [ Designated as safety issue: No ]
  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".
• Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ] [ Designated as safety issue: No ]
  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".
• Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week [ Time Frame: Up to 48 weeks (Baseline to last measurement) ] [ Designated as safety issue: No ]
  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".
• Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ] [ Designated as safety issue: No ]
  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".
• Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48 [ Time Frame: Up to 48 weeks (Baseline to last measurement) ] [ Designated as safety issue: No ]
  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".
• Number of Participants With Adverse Events [ Time Frame: Up to 70 weeks at the longest ] [ Designated as safety issue: Yes ]
  Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.

• Degree of gastric mucosal lesion by modified LANZA score. Presence/absence and severity of RE evaluated by the LA classification [ Time Frame: Up to 12, 24, 36, 48, 60 and 72 weeks after randomisation ] [ Designated as safety issue: No ]
• Presence/absence and severity of gastrointestinal symptoms assessed by the investigator(s) at each visit [ Time Frame: Every 4 weeks up to 72 weeks after dandomization ] [ Designated as safety issue: No ]
• Adverse events, Clinical laboratory values, Vital signs [ Time Frame: Every 4 weeks up to 72 weeks after dandomization ] [ Designated as safety issue: Yes ]

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.

• Drug: Esomeprazole
  20mg, capsule, 72 weeks
• Drug: Placebo
  Placebo, capsule, 72 weeks

• Experimental: Esomeprazole 20mg
  Esomeprazole 20mg once daily oral
  Intervention: Drug: Esomeprazole
• Placebo Comparator: Placebo
  Placebo once daily oral
  Intervention: Drug: Placebo

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.