Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on LDA (Oberon)

The purpose of this study is to compare the effect of esomeprazole 20 and 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Official Title

A Randomized, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 and 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)

Conditions

Gastric Ulcer, Duodenal Ulcer

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

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

Secondary Outcome Measures:

• 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

Study Start

February 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Daily intake of low-dose 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 naive to low-dose ASA (ie, treatment started within 1 month prior to randomization).
  • Aged >60 years with stable coronary artery disease.
  • Aged >60 years with complaints of upper GI symptoms that, as judged by the investigator, requires an EGD and with the finding of >=5 gastric and/or duodenal erosions at the baseline endoscopy.

Exclusion Criteria:

• Peptic ulcer(s) at baseline 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.

Total Enrolment

2400

Contact Details

Australian Locations:

• CARINA HEIGHTS, Australia; Recruiting
• CABOOLTURE, Australia; Not yet recruiting
• BALLARAT, Australia; Not yet recruiting
• BOX HILL, Australia; Not yet recruiting
• GEELONG, Australia; Not yet recruiting
• ADELAIDE, Australia; Not yet recruiting

For more information, contact Astra-Zeneca