Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately - Full Text View

Purpose

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Aspirin Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period [ Time Frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period [ Time Frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing ] [ Designated as safety issue: No ]
Median 24-hour intragastric pH [ Time Frame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing ] [ Designated as safety issue: No ]
Gastrointestinal symptom (Global Overall Symptoms questionnaire) [ Time Frame: GOS questionnaire will be adminsited on day 5 ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	November 2009
Study Completion Date:	March 2010

Arms	Assigned Interventions
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 Name: Nexium Drug: ASA Tablet, oral, single dose Other Name: 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 Name: Nexium Drug: ASA Tablet, oral, single dose Other Name: Aspirin

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015729

Locations

Canada, Ontario
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)

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01015729 History of Changes
Other Study ID Numbers:	D961FC00008
Study First Received:	November 17, 2009
Last Updated:	January 13, 2012
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Bioequivalence
ASA
Esomeprazole
peptic ulcer disease
pH measurements

Additional relevant MeSH terms:

Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Aspirin
Omeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013