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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)

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ClinicalTrials.gov Identifier: NCT00441727
Recruitment Status : Completed
First Posted : March 1, 2007
Results First Posted : February 13, 2012
Last Update Posted : July 16, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE February 27, 2007
First Posted Date  ICMJE March 1, 2007
Results First Submitted Date  ICMJE August 28, 2009
Results First Posted Date  ICMJE February 13, 2012
Last Update Posted Date July 16, 2012
Study Start Date  ICMJE February 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s). [ Time Frame: During 26 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2007)
The primary variable is time to occurrence of peptic ulcer(s).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
  • Percentage of Participants Who Experienced the Occurence of Gastric Ulcer. [ Time Frame: During 26 weeks ]
    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.
  • Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer. [ Time Frame: During 26 weeks ]
    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.
  • 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. ]
    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.
  • 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. ]
    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.
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2007)
  • Time to occurrence of gastric/duodenal ulcer.
  • Dichotomized RDQ score for the dyspepsia/GERD dimension
  • Number of gastric/duodenal erosions
  • Adverse events, lab and vital signs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Gastric Ulcer
  • Duodenal Ulcer
Intervention  ICMJE
  • Drug: Esomeprazole 40 mg
    Esomeprazole 40 mg once daily
  • Drug: Esomeprazole 20 mg
    Esomeprazole 20 mg once daily
  • Drug: Placebo
    Placebo once daily
Study Arms  ICMJE
  • Experimental: Esomeprazole 40 mg
    Esomeprazole 40 mg
    Intervention: Drug: Esomeprazole 40 mg
  • Experimental: Esomeprazole 20 mg
    Esomeprazole 20 mg
    Intervention: Drug: Esomeprazole 20 mg
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2008)
2426
Original Enrollment  ICMJE
 (submitted: February 27, 2007)
2400
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Australia,   Canada,   Czech Republic,   Finland,   Germany,   Indonesia,   Korea, Republic of,   Mexico,   Norway,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa,   Thailand,   United States
Removed Location Countries Hungary
 
Administrative Information
NCT Number  ICMJE NCT00441727
Other Study ID Numbers  ICMJE D961FC00003
EudraCT No. 2006-005073-22
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tore Lind, MD, PhD AstraZeneca
Principal Investigator: James Scheiman, MD University of Michigan
PRS Account AstraZeneca
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP