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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole/ASA Fixed Combination
  • Capsule, oral, single dose
• Drug: Esomeprazole
  • oral, single dose
• Drug: ASA
  • Tablet, oral, single dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Esomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule
• Active Comparator: 2
  • Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
• Active Comparator: 3
  • Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Primary Measures

• Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period
  • Time Frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
    Safety Issue?: No

Secondary Measures

• Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period
  • Time Frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
    Safety Issue?: No
• Median 24-hour intragastric pH
  • Time Frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
    Safety Issue?: No
• Gastrointestinal symptom (Global Overall Symptoms questionnaire)
  • Time Frame: GOS questionnaire will be adminsited on day 5
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

TJorgen Nasdal, MD, PhD Study Director AstraZeneca R&D  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01015729

Study ID Number: D961FC00008

ClinicalTrials.gov Identifier: NCT01015729

Health Authority: Canada: Health Canada