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NCT00441727 Clinical 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)

Gastric Ulcer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00441727
Other study ID # D961FC00003
Secondary ID EudraCT No. 2006
Status Completed
Phase Phase 3
First received February 27, 2007
Last updated July 12, 2012
Start date February 2007
Est. completion date August 2008

Study information
Verified date July 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBulgaria: Bulgarian Drug AgencyCanada: Health CanadaCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyMexico: Federal Commission for Protection Against Health RisksNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines AgencyRussia: Pharmacological Committee, Ministry of HealthSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilPhilippines: Bureau of Food and DrugsSouth Korea: Korea Food and Drug Administration (KFDA)Thailand: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2426
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Esomeprazole 40 mg
Esomeprazole 40 mg once daily
• Esomeprazole 20 mg
Esomeprazole 20 mg once daily
• Placebo
Placebo once daily

Locations
Country Name City State
Argentina Research Site Buenos Aires Buenos Aires- Argentina
Argentina Research Site Capital Federal Buenos Aires
Argentina Research Site Loma Hermosa Buenos Aires
Argentina Research Site Lomas de Zamora Buenos Aires
Argentina Research Site Mendoza
Argentina Research Site Rosario
Argentina Research Site Rosario Santa Fe
Australia Research Site Adelaide South Australia
Australia Research Site Ballarat Victoria
Australia Research Site Box Hill Victoria
Australia Research Site Caboolture Queensland
Australia Research Site Carina Heights Queensland
Australia Research Site Geelong Victoria
Australia Research Site NSW
Bulgaria Research Site Chirpan
Bulgaria Research Site Pleven
Bulgaria Research Site Rousse
Bulgaria Research Site Sofia
Bulgaria Research Site Varna
Canada Research Site Bay Roberts Newfoundland and Labrador
Canada Research Site Brampton Ontario
Canada Research Site Calgary Alberta
Canada Research Site Cambridge Ontario
Canada Research Site Carbonear Newfoundland and Labrador
Canada Research Site Edmonton Alberta
Canada Research Site Hamilton Ontario
Canada Research Site Laval
Canada Research Site Longueuil
Canada Research Site Mount Pearl Newfoundland and Labrador
Canada Research Site Niagara Falls Ontario
Canada Research Site North York Ontario
Canada Research Site Pointe-claire Quebec
Canada Research Site Quebec
Canada Research Site St. John's Newfoundland and Labrador
Canada Research Site St. John`s Newfoundland and Labrador
Canada Research Site Tillsonburg Ontario
Canada Research Site Toronto Ontario
Czech Republic Research Site Beroun
Czech Republic Research Site Brno
Czech Republic Research Site Liberec
Czech Republic Research Site Litomerice
Czech Republic Research Site Ostrava - Trebovice
Czech Republic Research Site Podborany
Czech Republic Research Site Poobram
Czech Republic Research Site Praha 1
Czech Republic Research Site Praha 4 - Sporilov
Czech Republic Research Site Praha 6
Czech Republic Research Site Praha 9
Czech Republic Research Site Tabor
Finland Research Site Joensuu
Finland Research Site Mikkeli
Finland Research Site Pietarsaari
Finland Research Site Tampere
Finland Research Site Turku
Finland Research Site Vantaa
Germany Research Site Bochum
Germany Research Site Dresden
Germany Research Site Ludwigshafen
Germany Research Site Luedenscheid
Germany Research Site Magdeburg
Germany Research Site Munchen
Germany Research Site Oelde
Germany Research Site Potsdam
Germany Research Site Rodgau-dudenhofen
Germany Research Site Siegen
Germany Research Site Wangen
Germany Research Site Wolmirstedt
Indonesia Research Site Jakarta
Indonesia Research Site Semarang
Indonesia Research Site Surabaya
Indonesia Research Site Yogyakarta
Korea, Republic of Research Site Seongnam-si Kyeonggi-do
Korea, Republic of Research Site Seoul
Mexico Research Site D.F
Mexico Research Site Guadalajara Jalisco
Mexico Research Site Mexico D.f.
Mexico Research Site Mexico City
Mexico Research Site Zapopan Jalisco
Norway Research Site Asker
Norway Research Site Bergen
Norway Research Site Elverum
Norway Research Site Gjovik
Norway Research Site Hamar
Norway Research Site Levanger
Norway Research Site Lysaker
Norway Research Site Olesund
Norway Research Site Oslo
Norway Research Site Osteros
Norway Research Site Paradis
Norway Research Site Stavanger
Norway Research Site Tromso
Philippines Research Site Manila
Philippines Research Site Quezon City
Poland Research Site Bydgoszcz
Poland Research Site Chojnice
Poland Research Site Chrzanow
Poland Research Site Czechowice-dziedzice
Poland Research Site Czestochowa
Poland Research Site Elblog
Poland Research Site Gdansk
Poland Research Site Gdynia
Poland Research Site Ilawa
Poland Research Site Koscierzyna
Poland Research Site Krakow
Poland Research Site Sopot
Poland Research Site Tczew
Poland Research Site Warszawa
Portugal Research Site Angra Do Herosmo
Portugal Research Site Braga
Portugal Research Site Castelo Branco
Portugal Research Site Coimbra
Portugal Research Site Covilha
Portugal Research Site Lisboa
Portugal Research Site Setubal
Portugal Research Site Vila Real
Romania Research Site Brasov
Romania Research Site Bucharest
Romania Research Site Iasi
Romania Research Site Satu-mare
Romania Research Site Tg. Mures
Russian Federation Research Site Moscow
Russian Federation Research Site Saint- Petersburg
Slovakia Research Site Banovce Nad Bebravou
Slovakia Research Site Banska Bysterica
Slovakia Research Site Brastislava
Slovakia Research Site Liptovsky Mikulas
Slovakia Research Site Martin
Slovakia Research Site Nitra
Slovakia Research Site Nove Mesto Nad Vahom
Slovakia Research Site Piestany
Slovakia Research Site Povazska Bystrica
Slovakia Research Site Trnava
South Africa Research Site Cape Town
South Africa Research Site Durban
South Africa Research Site Johannesburg
Thailand Research Site Bangkok
Thailand Research Site Chiang Mai
United States Research Site Albuquerque New Mexico
United States Research Site Anaheim California
United States Research Site Anderson South Carolina
United States Research Site Baltimore Maryland
United States Research Site Birmingham Alabama
United States Research Site Boynton Beach Florida
United States Research Site Brockton Massachusetts
United States Research Site Burke Virginia
United States Research Site Centerville Ohio
United States Research Site Chesapeake Virginia
United States Research Site Christiansburg Virginia
United States Research Site Cincinnati Ohio
United States Research Site Cranston Rhode Island
United States Research Site Dayton Ohio
United States Research Site Egg Harbor Township New Jersey
United States Research Site Fayetteville North Carolina
United States Research Site Fulton Illinois
United States Research Site Great Neck New York
United States Research Site Greensboro North Carolina
United States Research Site Guthrie Oklahoma
United States Research Site Harrisburg Pennsylvania
United States Research Site Hollywood Maryland
United States Research Site Hollywood Florida
United States Research Site Houston Texas
United States Research Site Jackson Mississippi
United States Research Site Jacksonville North Carolina
United States Research Site Jacksonville Florida
United States Research Site Johnston Rhode Island
United States Research Site Jupiter Florida
United States Research Site Knoxville Tennessee
United States Research Site Lancaster California
United States Research Site Las Vegas Nevada
United States Research Site Los Angeles California
United States Research Site Miami Florida
United States Research Site Milwaukee Wisconsin
United States Research Site New Smyrna Beach Florida
United States Research Site Norfolk Virginia
United States Research Site Ogden Utah
United States Research Site Oklahoma City Oklahoma
United States Research Site Orange California
United States Research Site Pembroke Pines Florida
United States Research Site Plantation Florida
United States Research Site Prince Frederick Maryland
United States Research Site Richmond Virginia
United States Research Site San Carlos California
United States Research Site San Diego California
United States Research Site Shreveport Louisiana
United States Research Site Simpsonville South Carolina
United States Research Site South Miami Florida
United States Research Site Tampa Florida
United States Research Site Torrington Connecticut
United States Research Site Tucson Arizona
United States Research Site Wichita Kansas
United States Research Site Winston-salem North Carolina
United States Research Site Zephyrhills Florida

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Canada,  Czech Republic,  Finland,  Germany,  Indonesia,  Korea, Republic of,  Mexico,  Norway,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  South Africa,  Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. During 26 weeks No
Secondary 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. During 26 weeks No
Secondary 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. During 26 weeks No
Secondary 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. RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal. No
Secondary 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. RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal. No
Secondary Number of Participants With Gastric and/or Duodenal Erosions. The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal. No
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