Phase 3
N=427
Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
Prevention
Bottom Line
View on ClinicalTrials.gov: NCT01069939 ↗Enrolled (actual)
427
Serious AEs
7.5%
Results posted
Nov 2012
Primary outcome: Primary: Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. — 1; 16; 1; 4 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esomeprazole (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to Occurrence of Gastric and/or Duodenal Ulcers up to Data Cut-off Date for Interim Analysis. |
1; 16; 1; 4; 0; 2 | <0.001 sig |
| SECONDARY Change in Degree of Gastric Mucosal Lesion by Modified Lanza Scale From Baseline to Last Measurement up to Week 48 |
-0.4; 1.3 | — |
| SECONDARY Number of Participants With Reflux Esophagitis Evaluated by the LA Classification up to Week 48. |
0; 9; 1; 6; 0; 3 | — |
| SECONDARY Change in the Severity of Epigastric Pain From Baseline to Last Measurement up to Week 48 |
11; 16; 153; 145; 4; 11 | — |
| SECONDARY Change in the Severity of Heartburn From Baseline to Last Measurement up to Week 48. |
7; 6; 158; 154; 3; 12 | — |
| SECONDARY Change in the Severity of Anorexia From Baseline to Last Measurement up to Week 48 |
9; 10; 156; 153; 3; 9 | — |
| SECONDARY Change in the Severity of Abdomen Enlarged Feeling From Baseline to Last Measurement up to Week |
18; 24; 141; 141; 9; 7 | — |
| SECONDARY Change in the Severity of Nausea and/or Vomiting From Baseline to Last Measurement up to Week 48 |
8; 5; 160; 154; 0; 13 | — |
| SECONDARY Change in the Severity of Discomfort in the Stomach From Baseline to Last Measurement up to Week 48 |
13; 15; 150; 148; 5; 9 | — |
| SECONDARY Number of Participants With Adverse Events |
155; 139; 70; 53; 0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01069939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.