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

Peptic Ulcer Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01015729
• Other study ID #: D961FC00008
• Status: Terminated
• Phase: Phase 1
• First received: November 17, 2009
• Last updated: January 13, 2012
• Start date: November 2009
• Est. completion date: March 2010

Study information

• Verified date: January 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Disease

Intervention

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

Locations

Country	Name	City	State
Canada	Research Site	Scarborough	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Median 24-hour intragastric pH		pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing	No
Secondary	Gastrointestinal symptom (Global Overall Symptoms questionnaire)		GOS questionnaire will be adminsited on day 5	No