NCT01015729

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 16, 2012

Status Verified

January 1, 2012

First QC Date

November 17, 2009

Last Update Submit

January 13, 2012

Conditions

Peptic Ulcer Disease

Keywords

BioequivalenceASAEsomeprazolepeptic ulcer diseasepH measurements

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

1

ACTIVE COMPARATOR

Esomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule

Drug: Esomeprazole/ASA Fixed Combination

2

ACTIVE COMPARATOR

Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg

Drug: EsomeprazoleDrug: ASA

3

ACTIVE COMPARATOR

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

Drug: EsomeprazoleDrug: ASA

Interventions

Esomeprazole/ASA Fixed CombinationDRUG

Capsule, oral, single dose

1
EsomeprazoleDRUG

oral, single dose

Also known as: Nexium
23
ASADRUG

Tablet, oral, single dose

Also known as: Aspirin
23

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Scarborough Village, Ontario, Canada

Location

MeSH Terms

Conditions

Peptic Ulcer

Interventions

EsomeprazoleAspirin

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • TJorgen Nasdal, MD, PhD

    AstraZeneca R&D

    STUDY DIRECTOR

  • Pierre Geoffroy, M.D. C.M., M.Sc., F.C.F.P.

    Biovail Contract Research (BCR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 18, 2009

Study Start

November 1, 2009

Study Completion

March 1, 2010

Last Updated

January 16, 2012

Record last verified: 2012-01

Locations

CA(1)