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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,426
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
The occurrence of ulcer (mucosal break measuring \>= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Time frame: During 26 weeks
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
The occurrence of gastric ulcer (mucosal break measuring \>= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Time frame: During 26 weeks
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
The occurrence of duodenal ulcer (mucosal break measuring \>= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Time frame: During 26 weeks
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.
RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.
Time frame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Birmingham, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Anaheim, California, United States
Research Site
Lancaster, California, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
San Carlos, California, United States
Research Site
San Diego, California, United States
Research Site
Torrington, Connecticut, United States
Research Site
Boynton Beach, Florida, United States
...and 179 more locations
RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.
Time frame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Number of Participants With Gastric and/or Duodenal Erosions.
Time frame: The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.