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

February 27, 2007
July 12, 2012
February 2007
August 2008   (final data collection date for primary outcome measure)
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s). [ Time Frame: During 26 weeks ] [ Designated as safety issue: No ]
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.
The primary variable is time to occurrence of peptic ulcer(s).
Complete list of historical versions of study NCT00441727 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Experienced the Occurence of Gastric Ulcer. [ Time Frame: During 26 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
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)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Gastric Ulcer
  • Duodenal Ulcer
  • Drug: Esomeprazole 40 mg
    Esomeprazole 40 mg once daily
  • Drug: Esomeprazole 20 mg
    Esomeprazole 20 mg once daily
  • Drug: Placebo
    Placebo once daily
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2426
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   Argentina,   Australia,   Bulgaria,   Canada,   Czech Republic,   Finland,   Thailand,   Indonesia,   Korea, Republic of,   Mexico,   Norway,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa
 
NCT00441727
D961FC00003, EudraCT No. 2006-005073-22
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Tore Lind, MD, PhD AstraZeneca
Principal Investigator: James Scheiman, MD University of Michigan
AstraZeneca
July 2012

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