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) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastric Ulcer Duodenal Ulcer	Drug: Esomeprazole 40 mg Drug: Esomeprazole 20 mg Drug: Placebo	Phase 3

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
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)

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Aspirin Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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 ]

Enrollment:	2426
Study Start Date:	February 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Esomeprazole 40 mg Esomeprazole 40 mg	Drug: Esomeprazole 40 mg Esomeprazole 40 mg once daily
Experimental: Esomeprazole 20 mg Esomeprazole 20 mg	Drug: Esomeprazole 20 mg Esomeprazole 20 mg once daily
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo once daily

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441727

Show 192 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tore Lind, MD, PhD	AstraZeneca
Principal Investigator:	James Scheiman, MD	University of Michigan

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Scheiman JM, Devereaux PJ, Herlitz J, Katelaris PH, Lanas A, Veldhuyzen van Zanten S, Nauclér E, Svedberg LE. Prevention of peptic ulcers with esomeprazole in patients at risk of ulcer development treated with low-dose acetylsalicylic acid: a randomised, controlled trial (OBERON). Heart. 2011 May;97(10):797-802. Epub 2011 Mar 17.

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

Keywords provided by AstraZeneca:

Peptic ulcer
low-dose ASA

Additional relevant MeSH terms:

Duodenal Ulcer
Peptic Ulcer
Stomach Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Aspirin
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2012

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)