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

• Duodenal Ulcer
• Gastric Ulcer
• Peptic Ulcer
• Stomach Ulcer
• Ulcer

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

External Links

•   AstraZeneca Clinical Trial Information - Outside US