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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01015729
Other study ID # D961FC00008
Secondary ID
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
Est. primary completion date
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


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
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