Back to resultsStudy 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)
Primary Purpose
Gastric Ulcer, Duodenal Ulcer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole 40 mg
Esomeprazole 20 mg
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Ulcer focused on measuring Peptic ulcer, low-dose ASA
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.
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Esomeprazole 40 mg
Esomeprazole 20 mg
Placebo
Arm Description
Esomeprazole 40 mg
Esomeprazole 20 mg
Placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00441727
Brief Title
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)
Acronym
Oberon
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Ulcer, Duodenal Ulcer
Keywords
Peptic ulcer, low-dose ASA
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2426 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole 40 mg
Arm Type
Experimental
Arm Description
Esomeprazole 40 mg
Arm Title
Esomeprazole 20 mg
Arm Type
Experimental
Arm Description
Esomeprazole 20 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40 mg
Intervention Description
Esomeprazole 40 mg once daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 20 mg
Intervention Description
Esomeprazole 20 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
Description
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
Title
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
Description
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
Title
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.
Description
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.
Title
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.
Description
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.
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore Lind, MD, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
James Scheiman, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
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Facility Name
Research Site
City
Czechowice-dziedzice
Country
Poland
Facility Name
Research Site
City
Czestochowa
Country
Poland
Facility Name
Research Site
City
Elblog
Country
Poland
Facility Name
Research Site
City
Gdansk
Country
Poland
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Ilawa
Country
Poland
Facility Name
Research Site
City
Koscierzyna
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Sopot
Country
Poland
Facility Name
Research Site
City
Tczew
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Angra Do Herosmo
Country
Portugal
Facility Name
Research Site
City
Braga
Country
Portugal
Facility Name
Research Site
City
Castelo Branco
Country
Portugal
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Covilha
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Setubal
Country
Portugal
Facility Name
Research Site
City
Vila Real
Country
Portugal
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Satu-mare
Country
Romania
Facility Name
Research Site
City
Tg. Mures
Country
Romania
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Saint- Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Banovce Nad Bebravou
Country
Slovakia
Facility Name
Research Site
City
Banska Bysterica
Country
Slovakia
Facility Name
Research Site
City
Brastislava
Country
Slovakia
Facility Name
Research Site
City
Liptovsky Mikulas
Country
Slovakia
Facility Name
Research Site
City
Martin
Country
Slovakia
Facility Name
Research Site
City
Nitra
Country
Slovakia
Facility Name
Research Site
City
Nove Mesto Nad Vahom
Country
Slovakia
Facility Name
Research Site
City
Piestany
Country
Slovakia
Facility Name
Research Site
City
Povazska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Cape Town
Country
South Africa
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
23188121
Citation
Scheiman JM, Herlitz J, Veldhuyzen van Zanten SJ, Lanas A, Agewall S, Naucler EC, Svedberg LE, Nagy P. Esomeprazole for prevention and resolution of upper gastrointestinal symptoms in patients treated with low-dose acetylsalicylic acid for cardiovascular protection: the OBERON trial. J Cardiovasc Pharmacol. 2013 Mar;61(3):250-7. doi: 10.1097/FJC.0b013e31827cb626.
Results Reference
derived
PubMed Identifier
21415072
Citation
Scheiman JM, Devereaux PJ, Herlitz J, Katelaris PH, Lanas A, Veldhuyzen van Zanten S, Naucler E, Svedberg LE. Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON). Heart. 2011 May;97(10):797-802. doi: 10.1136/hrt.2010.217547. Epub 2011 Mar 17.
Results Reference
derived
Learn more about this trial
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)
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