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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01015729

Enrollment

Registered

2009-11-18

Start date

2009-11-30

Completion date

2010-03-31

Last updated

2012-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer Disease

Keywords

Bioequivalence, ASA, Esomeprazole, peptic ulcer disease, pH measurements

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.

Interventions

DRUGEsomeprazole/ASA Fixed Combination

Capsule, oral, single dose

DRUGEsomeprazole

oral, single dose

DRUGASA

Tablet, oral, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026