Phase 3
N=2,426
Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)
Gastric Ulcer · Duodenal Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT00441727 ↗Enrolled (actual)
2,426
Serious AEs
—
Results posted
Feb 2012
Primary outcome: Primary: Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s). — 1.35; 1; 6.58 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Esomeprazole 40 mg (Drug); Esomeprazole 20 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s). |
1.35; 1; 6.58 | — |
| SECONDARY Percentage of Participants Who Experienced the Occurence of Gastric Ulcer. |
1.1; 0.75; 4.1 | — |
| SECONDARY Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer. |
0.24; 0.25; 2.73 | — |
| SECONDARY Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit. |
591; 577; 504 | — |
| SECONDARY Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit. |
554; 537; 451 | — |
| SECONDARY Number of Participants With Gastric and/or Duodenal Erosions. |
214; 213; 380 | — |
Summary
The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.
Eligibility Criteria
Inclusion Criteria
- Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e):
- Aged ≥65 years.
- Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
- Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).
- Aged ≥60 years and with stable coronary artery disease.
- Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.
Exclusion Criteria
- Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
- Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
- History of peptic ulcer complications such as clinically significant bleeding and/or perforation.
Data sourced from ClinicalTrials.gov (NCT00441727). 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.