Clinical trial 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)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcer
Duodenal Ulcer
Keywords: Peptic ulcer
low-dose ASA
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 2426
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
timeFrame: During 26 weeks
Secondary outcomes:
measure: Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
timeFrame: During 26 weeks
measure: Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
timeFrame: During 26 weeks
measure: 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.
timeFrame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
measure: 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.
timeFrame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
measure: Number of Participants With Gastric and/or Duodenal Erosions.
timeFrame: The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
Other outcomes:
Locations:
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country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Anaheim
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state: California
city: Lancaster
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city: Los Angeles
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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country: Portugal
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city: Vila Real
country: Portugal
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city: Brasov
country: Romania
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city: Bucharest
country: Romania
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city: Iasi
country: Romania
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city: Satu-mare
country: Romania
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city: Tg. Mures
country: Romania
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city: Moscow
country: Russian Federation
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city: Saint- Petersburg
country: Russian Federation
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city: Banovce Nad Bebravou
country: Slovakia
facility: Research Site
city: Banska Bysterica
country: Slovakia
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country: Slovakia
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city: Liptovsky Mikulas
country: Slovakia
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city: Martin
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city: Nitra
country: Slovakia
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city: Nove Mesto Nad Vahom
country: Slovakia
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city: Piestany
country: Slovakia
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city: Povazska Bystrica
country: Slovakia
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country: Slovakia
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city: Cape Town
country: South Africa
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country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Tore Lind, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: James Scheiman, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.