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

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ClinicalTrials.gov Identifier: NCT01015729
Recruitment Status : Terminated
First Posted : November 18, 2009
Last Update Posted : January 16, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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 Type : Interventional  (Clinical Trial)
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 : November 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Gastrointestinal symptom (Global Overall Symptoms questionnaire) [ Time Frame: GOS questionnaire will be adminsited on day 5 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01015729     History of Changes
Other Study ID Numbers: D961FC00008
First Posted: November 18, 2009    Key Record Dates
Last Update Posted: January 16, 2012
Last Verified: January 2012

Keywords provided by AstraZeneca:
Bioequivalence
ASA
Esomeprazole
peptic ulcer disease
pH measurements

Additional relevant MeSH terms:
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Aspirin
Esomeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors