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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01015729
First received: November 17, 2009
Last updated: January 13, 2012
Last verified: January 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014