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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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)
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)
Secondary ID [1] 0 0
EudraCT No. 2006-005073-22
Secondary ID [2] 0 0
D961FC00003
Universal Trial Number (UTN)
Trial acronym
Oberon
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Ulcer 0 0
Duodenal Ulcer 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
During 26 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
During 26 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
During 26 weeks
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. - 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.
Timepoint [3] 0 0
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Secondary outcome [4] 0 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. - 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.
Timepoint [4] 0 0
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Secondary outcome [5] 0 0
Number of Participants With Gastric and/or Duodenal Erosions.
Timepoint [5] 0 0
The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Caboolture
Recruitment hospital [2] 0 0
Research Site - Carina Heights
Recruitment hospital [3] 0 0
Research Site - Adelaide
Recruitment hospital [4] 0 0
Research Site - Ballarat
Recruitment hospital [5] 0 0
Research Site - Box Hill
Recruitment hospital [6] 0 0
Research Site - Geelong
Recruitment hospital [7] 0 0
Research Site - NSW
Recruitment postcode(s) [1] 0 0
- Caboolture
Recruitment postcode(s) [2] 0 0
- Carina Heights
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Ballarat
Recruitment postcode(s) [5] 0 0
- Box Hill
Recruitment postcode(s) [6] 0 0
- Geelong
Recruitment postcode(s) [7] 0 0
- NSW
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Mississippi
Country [12] 0 0
United States of America
State/province [12] 0 0
Nevada
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New Mexico
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Rhode Island
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
Buenos Aires- Argentina
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Argentina
State/province [30] 0 0
Mendoza
Country [31] 0 0
Argentina
State/province [31] 0 0
Rosario
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Chirpan
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Pleven
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Rousse
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Sofia
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Varna
Country [37] 0 0
Canada
State/province [37] 0 0
Alberta
Country [38] 0 0
Canada
State/province [38] 0 0
Newfoundland and Labrador
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Canada
State/province [41] 0 0
Laval
Country [42] 0 0
Canada
State/province [42] 0 0
Longueuil
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Beroun
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Brno
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Liberec
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Litomerice
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Ostrava - Trebovice
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Podborany
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Poobram
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Praha 1
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Praha 4 - Sporilov
Country [52] 0 0
Czech Republic
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Praha 6
Country [53] 0 0
Czech Republic
State/province [53] 0 0
Praha 9
Country [54] 0 0
Czech Republic
State/province [54] 0 0
Tabor
Country [55] 0 0
Finland
State/province [55] 0 0
Joensuu
Country [56] 0 0
Finland
State/province [56] 0 0
Mikkeli
Country [57] 0 0
Finland
State/province [57] 0 0
Pietarsaari
Country [58] 0 0
Finland
State/province [58] 0 0
Tampere
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Finland
State/province [59] 0 0
Turku
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Finland
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Vantaa
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Bochum
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Germany
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Dresden
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Germany
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Ludwigshafen
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Germany
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Luedenscheid
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Germany
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Magdeburg
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Germany
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Munchen
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Germany
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Oelde
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Germany
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Potsdam
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Germany
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Rodgau-dudenhofen
Country [70] 0 0
Germany
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Siegen
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Germany
State/province [71] 0 0
Wangen
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Germany
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Wolmirstedt
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Jakarta
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Indonesia
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Semarang
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Indonesia
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Surabaya
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Indonesia
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Yogyakarta
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Korea, Republic of
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Kyeonggi-do
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Korea, Republic of
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Seoul
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Mexico
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D.f.
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Mexico
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Jalisco
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Mexico
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D.F
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Mexico
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Mexico City
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Norway
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Asker
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Elverum
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Hamar
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Norway
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Lysaker
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Olesund
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Norway
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Oslo
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Paradis
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Manila
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Philippines
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Quezon City
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Czechowice-dziedzice
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Gdynia
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Ilawa
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Koscierzyna
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Poland
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Krakow
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Poland
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Sopot
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Poland
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Tczew
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Coimbra
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Lisboa
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Portugal
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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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Martin
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Slovakia
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Nitra
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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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Cape Town
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South Africa
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Durban
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South Africa
State/province [139] 0 0
Johannesburg
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Thailand
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Bangkok
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Thailand
State/province [141] 0 0
Chiang Mai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00441727
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tore Lind, MD, PhD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications