Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately

An Open-Label, Randomized, Single-Center, 3-Way Crossover Study Comparing The Therapeutic Efficacy of a Fixed Dose Combination Capsule of Esomeprazole 20 mg And Acetylsalicylic Acid (ASA) 81 mg With Free Combinations of ASA Tablet 81 mg And Esomeprazole 20 mg as a Capsule or Tablet in Patients At Risk of Gastrointestinal Events Using Low Dose ASA for Cardiovascular Protection

The purpose of this study is to investigate whether a fixed dose combination (FDC) capsule of esomeprazole 20 mg and acetylsalicylic acid (ASA) 81 mg has equivalent therapeutic efficacy compared to each of 2 free combinations of ASA tablet 81 mg plus esomeprazole 20 mg in patients at risk of gastrointestinal events using low dose ASA for cardiovascular protection.

Study Overview

• Status: Terminated
• Conditions: Peptic Ulcer Disease
• Intervention / Treatment: Drug: Esomeprazole/ASA Fixed Combination; Drug: ASA; Drug: Esomeprazole

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Scarborough, Ontario, Canada
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non-smoking male and female subjects, aged 18 years or older with a documented history of uncomplicated peptic ulcer(s), or aged 65 years or older
• Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 35.0 kg/m2

Exclusion Criteria:

• Known history of hypersensitivity to esomeprazole (e.g. Nexium®) or related drugs such as omeprazole (e.g. Losec®, Prilosec®), lansoprazole (e.g. Prevacid®, Hp-PAC®), pantoprazole (e.g. Pantoloc®, PANTO® IV), or rabeprazole (e.g. Pariet™), a known hypersensitivity to ASA (e.g. Aspirin®) and/or related drugs such as ibuprofen (e.g. Motrin®, Advil®), indomethacin (e.g. Indocin®), diclofenac (e.g. Voltaren®), naproxen (e.g. Aleve®, Naprosyn®), or ketoprofen (e.g. Rhovail®).
• Significant history of pulmonary, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, or gastrointestinal disease (with the exception of uncomplicated peptic ulcer), unless deemed NCS by the Principal Investigator or Sub-investigator

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Esomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule	Drug: Esomeprazole/ASA Fixed Combination; Capsule, oral, single dose
Active Comparator: 2; Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg	Drug: ASA; Tablet, oral, single dose; Other Names: Aspirin; Drug: Esomeprazole; oral, single dose; Other Names: Nexium
Active Comparator: 3; Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg	Drug: ASA; Tablet, oral, single dose; Other Names: Aspirin; Drug: Esomeprazole; oral, single dose; Other Names: Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period	pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period	pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Median 24-hour intragastric pH	pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Gastrointestinal symptom (Global Overall Symptoms questionnaire)	GOS questionnaire will be adminsited on day 5

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: TJorgen Nasdal, MD, PhD, AstraZeneca R&D; Principal Investigator: Pierre Geoffroy, M.D. C.M., M.Sc., F.C.F.P., Biovail Contract Research (BCR)

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: November 17, 2009
• First Submitted That Met QC Criteria: November 17, 2009
• First Posted (Estimate): November 18, 2009

Study Record Updates

• Last Update Posted (Estimate): January 16, 2012
• Last Update Submitted That Met QC Criteria: January 13, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Bioequivalence; peptic ulcer disease; Esomeprazole; ASA; pH measurements
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Duodenal Diseases; Peptic Ulcer; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: D961FC00008