Study Comparing Esomeprazole and ASA Combined Together as One Capsule Versus These Medications Taken Separately
Phase 1
Terminated
- Conditions
- Peptic Ulcer Disease
- Interventions
- Registration Number
- NCT01015729
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 ASA Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg 1 Esomeprazole/ASA Fixed Combination Esomeprazole 20 mg/ASA 81 mg Fixed Dose Combination Capsule 2 Esomeprazole Esomeprazole Clinical Trial Capsule 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg 3 Esomeprazole Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg 3 ASA Esomeprazole MUPS Tablet 20 mg and 1 Aspirin® Non Enteric Coated Immediate Release Tablet 325 mg
- Primary Outcome Measures
Name Time Method Percentage of time that intragastric pH is maintained > 4.0 during the 24-hour recording period pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing
- Secondary Outcome Measures
Name Time Method Percentage of time that intragastric pH is maintained > 3.0 during the 24-hour recording period pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing Median 24-hour intragastric pH pH is measured over a 24-hour period following dosing on Day 5 after repeated oral administartion/dosing Gastrointestinal symptom (Global Overall Symptoms questionnaire) GOS questionnaire will be adminsited on day 5
Trial Locations
- Locations (1)
Research Site
🇨🇦Scarborough, Ontario, Canada