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)

Phase 3

Completed

• Conditions: Gastric Ulcer; Duodenal Ulcer
• Interventions: Drug: Placebo; Drug: Esomeprazole 20 mg; Drug: Esomeprazole 40 mg

• Registration Number: NCT00441727
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-27
• Study First Submitted QC: 2007-02-27
• Study First Posted: 2007-03-01
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-08-28
• Results First Submitted QC: 2012-01-10
• Results First Posted: 2012-02-13
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2426

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Esomeprazole 20 mg	Esomeprazole 20 mg	Esomeprazole 20 mg
Esomeprazole 40 mg	Esomeprazole 40 mg	Esomeprazole 40 mg

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).	During 26 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.	During 26 weeks	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.
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.	During 26 weeks	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.
Number of Participants With Gastric and/or Duodenal Erosions.	The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
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 was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.	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.
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.	RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.	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.

Trial Locations

Locations (1)

Research Site; 🇹🇭 Chiang Mai, Thailand