Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
- Registration Number
- NCT01069939
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 427
- 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.
- Having gastric or duodenal ulcer (except for ulcer scar).
- History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esomeprazole 20mg Esomeprazole Esomeprazole 20mg once daily oral Placebo Placebo Placebo once daily oral
- Primary Outcome Measures
Name Time Method Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. From randomisation to up to 48 weeks (Maximum follow-up period at the 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.
- Secondary Outcome Measures
Name Time Method Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48 Up to 48 weeks (Baseline to last measurement) 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. 12, 24, 36 and 48 weeks 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 Up to 48 weeks (Baseline to last measurement) 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. Up to 48 weeks (Baseline to last measurement) 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 Up to 48 weeks (Baseline to last measurement) 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 Up to 48 weeks (Baseline to last measurement) 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 Up to 48 weeks (Baseline to last measurement) 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 Up to 48 weeks (Baseline to last measurement) 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 Up to 70 weeks at the longest Participants who had at least adverse events (AE) which occurred after receiving study drug were counted.
Trial Locations
- Locations (1)
Research Site
🇨🇳Taipei, Taiwan