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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00441727
Registration number
NCT00441727
Ethics application status
Date submitted
27/02/2007
Date registered
1/03/2007
Date last updated
16/07/2012
Titles & IDs
Public 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)
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Scientific 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)
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Secondary ID [1]
0
0
EudraCT No. 2006-005073-22
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Secondary ID [2]
0
0
D961FC00003
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Universal Trial Number (UTN)
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Trial acronym
Oberon
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Ulcer
0
0
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Duodenal Ulcer
0
0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Infection
0
0
0
0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Esomeprazole 40 mg
Treatment: Drugs - Esomeprazole 20 mg
Treatment: Drugs - Placebo
Experimental: Esomeprazole 40 mg - Esomeprazole 40 mg
Experimental: Esomeprazole 20 mg - Esomeprazole 20 mg
Placebo comparator: Placebo - Placebo
Treatment: Drugs: Esomeprazole 40 mg
Esomeprazole 40 mg once daily
Treatment: Drugs: Esomeprazole 20 mg
Esomeprazole 20 mg once daily
Treatment: Drugs: Placebo
Placebo once daily
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
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Assessment method [1]
0
0
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.
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Timepoint [1]
0
0
During 26 weeks
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Secondary outcome [1]
0
0
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
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Assessment method [1]
0
0
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.
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Timepoint [1]
0
0
During 26 weeks
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Secondary outcome [2]
0
0
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
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Assessment method [2]
0
0
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.
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Timepoint [2]
0
0
During 26 weeks
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Secondary outcome [3]
0
0
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.
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Assessment method [3]
0
0
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.
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Timepoint [3]
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0
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
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Secondary outcome [4]
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0
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.
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Assessment method [4]
0
0
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.
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Timepoint [4]
0
0
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
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Secondary outcome [5]
0
0
Number of Participants With Gastric and/or Duodenal Erosions.
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Assessment method [5]
0
0
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Timepoint [5]
0
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The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
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Eligibility
Key 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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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2008
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Sample size
Target
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Accrual to date
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Final
2426
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Caboolture
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Research Site - Carina Heights
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- Caboolture
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- Carina Heights
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- Adelaide
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- Ballarat
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- Box Hill
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- Geelong
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- NSW
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Recruitment outside Australia
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Setubal
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Portugal
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Vila Real
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Iasi
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Romania
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Satu-mare
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Romania
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Tg. Mures
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Russian Federation
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Moscow
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Russian Federation
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Saint- Petersburg
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Slovakia
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Banovce Nad Bebravou
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Slovakia
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Banska Bysterica
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Slovakia
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Brastislava
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Slovakia
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Liptovsky Mikulas
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Slovakia
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Martin
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Slovakia
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Nitra
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Slovakia
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Nove Mesto Nad Vahom
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Slovakia
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Piestany
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Slovakia
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Povazska Bystrica
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Slovakia
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Trnava
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00441727
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Trial related presentations / publications
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. 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.
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Public notes
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Contacts
Principal investigator
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Tore Lind, MD, PhD
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00441727
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