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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) (Oberon)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00441727
First received: February 27, 2007
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Gastric Ulcer
Duodenal Ulcer
Drug: Esomeprazole 40 mg
Drug: Esomeprazole 20 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s). [ Time Frame: During 26 weeks ] [ Designated as safety issue: No ]
    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:
  • Percentage of Participants Who Experienced the Occurence of Gastric Ulcer. [ Time Frame: During 26 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: During 26 weeks ] [ Designated as safety issue: No ]
    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 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. ] [ Designated as safety issue: No ]
    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. [ Time Frame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]

Enrollment: 2426
Study Start Date: February 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Esomeprazole 40 mg
Esomeprazole 40 mg
Drug: Esomeprazole 40 mg
Esomeprazole 40 mg once daily
Experimental: Esomeprazole 20 mg
Esomeprazole 20 mg
Drug: Esomeprazole 20 mg
Esomeprazole 20 mg once daily
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00441727

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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tore Lind, MD, PhD AstraZeneca
Principal Investigator: James Scheiman, MD University of Michigan
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00441727     History of Changes
Other Study ID Numbers: D961FC00003, EudraCT No. 2006-005073-22
Study First Received: February 27, 2007
Results First Received: August 28, 2009
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Mexico: Federal Commission for Protection Against Health Risks
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Philippines: Bureau of Food and Drugs
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Food and Drug Administration

Keywords provided by AstraZeneca:
Peptic ulcer
low-dose ASA

Additional relevant MeSH terms:
Duodenal Ulcer
Peptic Ulcer
Stomach Ulcer
Ulcer
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Stomach Diseases
Aspirin
Esomeprazole
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Gastrointestinal Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 24, 2014