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) (Oberon)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00441727
First received: February 27, 2007
Last updated: July 12, 2012
Last verified: July 2012
Results First Received: August 28, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Gastric Ulcer
Duodenal Ulcer
Interventions: Drug: Esomeprazole 40 mg
Drug: Esomeprazole 20 mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first subject was randomized 22 February 2007 and last subject completed 28 August 2008. Cardiologists, primary care physicians and gastroenterologists were the primary target investigators.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Esomeprazole 40 Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Esomeproazole 20 Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
Placebo Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)

Participant Flow:   Overall Study
    Esomeprazole 40     Esomeproazole 20     Placebo  
STARTED     817 [1]   804 [1]   805 [1]
COMPLETED     711 [1]   686 [1]   637 [1]
NOT COMPLETED     106     118     168  
Protocol Violation                 19                 28                 32  
Adverse Event                 26                 33                 28  
Lack of Efficacy                 7                 8                 48  
Withdrawal by Subject                 40                 34                 47  
Lost to Follow-up                 5                 6                 5  
Safety Reasons                 3                 1                 3  
Various reason specified                 6                 8                 5  
[1] ITT/randomised



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Esomeprazole 40 Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
Esomeproazole 20 Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
Placebo Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
Total Total of all reporting groups

Baseline Measures
    Esomeprazole 40     Esomeproazole 20     Placebo     Total  
Number of Participants  
[units: participants]
  817     804     805     2426  
Age  
[units: Participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     240     246     260     746  
>=65 years     577     558     545     1680  
Gender  
[units: Participants]
       
Female     380     375     402     1157  
Male     437     429     403     1269  



  Outcome Measures
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1.  Primary:   Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).   [ Time Frame: During 26 weeks ]

2.  Secondary:   Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.   [ Time Frame: During 26 weeks ]

3.  Secondary:   Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.   [ Time Frame: During 26 weeks ]

4.  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.   [ Time Frame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal. ]

5.  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.   [ Time Frame: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal. ]

6.  Secondary:   Number of Participants With Gastric and/or Duodenal Erosions.   [ Time Frame: The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Not enough patients had peptic ulcer, gastric ulcer, or duodenal ulcer to report the intended primary endpoint of time to peptic ulcer and two secondary endpoints, time to gastric ulcer and time to duodenal ulcer. Percentage used instead.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00441727     History of Changes
Other Study ID Numbers: D961FC00003, EudraCT No. 2006-005073-22
Study First Received: February 27, 2007
Results First Received: August 28, 2009
Last Updated: July 12, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Mexico: Federal Commission for Protection Against Health Risks
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Russia: Pharmacological Committee, Ministry of Health
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Philippines: Bureau of Food and Drugs
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Food and Drug Administration