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Completed

NCT Number: NCT00441727

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)

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.

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Key information

Conditions

Gastric Ulcer Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

esomeprazole 40 mg

Drug

Esomeprazole 40 mg once daily

Esomeprazole 20 mg

Drug

Esomeprazole 20 mg once daily

Placebo

Drug

Placebo once daily

Primary outcomes

  1. Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).

    Time frame: 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 outcomes

  1. Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.

    Time frame: 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.

  2. Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.

    Time frame: 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.

  3. 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.

    Time frame: 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.

  4. 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.

    Time frame: 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Double-blind, Parallel-group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 or 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)

Acronym: Oberon

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 1, 2007
Registry last updated
Jul 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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