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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2007

Last Updated Date

July 12, 2012

Start Date ^ICMJE

February 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

The primary variable is time to occurrence of peptic ulcer(s).

Change History

Complete list of historical versions of study NCT00441727 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Enrollment ^ICMJE

2426

Completion Date

August 2008

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

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

Administrative Information

NCT Number ^ICMJE

NCT00441727

Other Study ID Numbers ^ICMJE

D961FC00003, EudraCT No. 2006-005073-22

Has Data Monitoring Committee

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

Information Provided By

AstraZeneca

Verification Date

July 2012

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

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