Clinical trial NCT01015729: Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Peptic Ulcer Disease
Keywords: Bioequivalence
ASA
Esomeprazole
peptic ulcer disease
pH measurements
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


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

Primary outcomes:
measure: Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period
timeFrame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
Secondary outcomes:
measure: Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period
timeFrame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
measure: Median 24-hour intragastric pH
timeFrame: pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
measure: Gastrointestinal symptom (Global Overall Symptoms questionnaire)
timeFrame: GOS questionnaire will be adminsited on day 5
Other outcomes:
Locations:
city: Scarborough
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: AstraZeneca R&D
name: TJorgen Nasdal, MD, PhD
role: STUDY_DIRECTOR
affiliation: Biovail Contract Research (BCR)
name: Pierre Geoffroy, M.D. C.M., M.Sc., F.C.F.P.
role: PRINCIPAL_INVESTIGATOR
References: