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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
427
20mg, capsule, 72 weeks
Placebo, capsule, 72 weeks
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.
Time frame: From randomisation to up to 48 weeks (Maximum follow-up period at the interim analysis)
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.
Time frame: 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.
Time frame: 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".
Time frame: Up to 48 weeks (Baseline to last measurement)
Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48.
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Research Site
Yotsukaidou, Chiba, Japan
Research Site
Fukui-shi, Fukui, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kitakyushu-Shi, Fukuoka, Japan
Research Site
Onga-Gun, Fukuoka, Japan
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Fukushima, Fukushima, Japan
Research Site
Kōriyama, Fukushima, Japan
Research Site
Nihommatsu, Fukushima, Japan
Research Site
Fukuyama, Hiroshima, Japan
...and 36 more locations
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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: Up to 70 weeks at the longest