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

NCT ID: NCT01015729

Last Updated: 2012-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-03-31

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.

Conditions

Peptic Ulcer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

1

Esomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule

Group Type: ACTIVE_COMPARATOR

Esomeprazole/ASA Fixed Combination

Intervention Type: DRUG

Capsule, oral, single dose

2

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

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

oral, single dose

ASA

Intervention Type: DRUG

Tablet, oral, single dose

3

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

Group Type: ACTIVE_COMPARATOR

Esomeprazole

Intervention Type: DRUG

oral, single dose

ASA

Intervention Type: DRUG

Tablet, oral, single dose

Interventions

Esomeprazole/ASA Fixed Combination

Capsule, oral, single dose

Intervention Type: DRUG

Esomeprazole

oral, single dose

Intervention Type: DRUG

ASA

Tablet, oral, single dose

Intervention Type: DRUG

Other Intervention Names

Nexium; Aspirin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

TJorgen Nasdal, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca R&D

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

Role: PRINCIPAL_INVESTIGATOR

Biovail Contract Research (BCR)

Locations

Research Site

Scarborough Village, Ontario, Canada

Countries

Canada

Other Identifiers

D961FC00008

Identifier Type: -

Identifier Source: org_study_id