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

Sponsor

AstraZeneca (Industry)

Overall Status

Terminated

CT.gov ID

NCT01015729

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer Disease	Drug: Esomeprazole/ASA Fixed Combination Drug: Esomeprazole Drug: ASA	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

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

Study Start Date :

Nov 1, 2009

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

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: Esomeprazole oral, single dose Other Names: Nexium Drug: ASA Tablet, oral, single dose Other Names: Aspirin
Active Comparator: 3 Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg	Drug: Esomeprazole oral, single dose Other Names: Nexium Drug: ASA Tablet, oral, single dose Other Names: Aspirin

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: Esomeprazole

oral, single dose

Other Names:

Nexium

Drug: ASA

Tablet, oral, single dose

Other Names:

Aspirin

Active Comparator: 3

Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Drug: Esomeprazole

oral, single dose

Other Names:

Nexium

Drug: ASA

Tablet, oral, single dose

Other Names:

Aspirin

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Scarborough	Ontario	Canada

Sponsors and Collaborators

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)