- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00442052
To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin
An Open-Label, Investigator-Blinded, Randomized, Parellel Group Study to Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA 325 Versus Enteric-Coated Aspirin.
Study Overview
Detailed Description
PA 325 is proposed for the reduction in the risk of aspirin-associated gastrointestinal (GI) adverse events in patients requiring daily aspirin. This study is designed as a Proof of Concept study to evaluate the gastroprotective effects, pharmacokinetic profile, and safety of PA 325 in healthy volunteers.
To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet combining 325 mg pH-sensitive aspirin and 20 mg immediate release omeprazole versus a once-daily dose of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H4R2N6
- MDS Pharma Services
-
-
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27517
- Pozen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
A subject will be eligible for inclusion in this study if all of the following criteria apply:
- Subject is a male or non-pregnant female
- Subject is 50-75 years of age
- Subject does not currently smoke
- Physical status within normal limits of age and consistent with observations at screening
- BMI of 20-30 kg/m2
Female subjects are eligible for participation in the study if they are of:
- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
Childbearing potential, have a negative pregnancy test (urine) at screening, and at least one of the following applies or is agreed to by the subject:
- Complete abstinence from intercourse for at least 14 days prior to first dose of study medication, throughout the study, and for 30 days after completion of the study
- Female sterilization or sterilization of male partner; or,
- Hormonal contraception by oral route, implant, injectable, vaginal ring; or,
- Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year;
- Double barrier method (2 physical barriers or 1 physical barrier plus spermicide); or
- Any other method with published data showing that the lowest expected failure rate is less than 1% per year
- Each subject must be able to understand and comply with study procedures required of a subject and is able and willing to provide written informed consent prior to any study procedures being performed
Exclusion Criteria:
- History of hypersensitivity to omeprazole or to another proton-pump inhibitor
- History of allergic reaction or intolerance to aspirin or any NSAIDs and/or subject has a history of NSAID-induced symptoms of asthma, rhinitis, and/or nasal polyps
- Participation in any study of an investigational treatment in the 4 weeks before Day 1 dosing
- Presence of uncontrolled acute or chronic medical illness, e.g. gastrointestinal disorder, diabetes, hypertension, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
- Gastrointestinal disorder or surgery leading to impaired drug absorption
- Evidence of uncontrolled, or unstable cardio- or cerebrovascular disorder, which in the investigator's opinion would endanger a subject if they were to participate in the study
- Schizophrenia or bipolar disorder
- Use of any concomitant medication not approved by the study physician during the washout period and during the study conduct
- Serious blood coagulation disorder including use of systemic anticoagulants
- Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to dosing
Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days;
- 1,500 mL of blood in 180 days;
- 2,500 mL of blood in 1 year.
- Baseline endoscopy showing any gastric or duodenal mucosal abnormality (hemorrhages, ulcers or erosions)
- Gastric pH > 3 at screening
- Screening laboratory value for ALT, AST >2 times the upper limit of normal
- Estimated creatinine clearance < 30 ml/min
- Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if they were to participate in the study
- History of hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infection, or demonstration of HIV antibodies
- History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
- Subjects who have previously been a screen failure in this study
- Subject has excessive alcohol use (> 2 units per day on average; for example 2 bottles of beer, two glasses of wine, 2 ounces of liquor/spirits), or recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence.
- Subject has ingested grapefruit or grapefruit juice within 10 days of dosing or will ingest grapefruit or grapefruit juice during the duration of the study.
- Positive illicit drug screen
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To compare the gastroprotective effects of a once-daily dose of PA 325
|
Secondary Outcome Measures
Outcome Measure |
---|
To evaluate the safety and GI tolerability including ulcerogenic potential, the pharmacokinetic profile, and the effect on gastric pH of PA 325
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Aspirin
- Omeprazole
Other Study ID Numbers
- PA325-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on aspirin
-
The First Affiliated Hospital with Nanjing Medical...UnknownCoronary AtherosclerosisChina
-
Seoul National University HospitalCKD Pharmaceutical LimitedCompleted
-
Queen Mary University of LondonCancer Research UK; Barts and the London School of Medicine and DentistryCompletedProstate CancerUnited Kingdom
-
FANG HERecruitingPreeclampsia | Perinatal HaemorrhageChina
-
University of VigoRecruiting
-
Seoul National University HospitalCompletedCoronary Artery DiseaseKorea, Republic of
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingPulmonary Disease, Chronic ObstructiveUnited States
-
Seoul National University HospitalCompletedHealthyKorea, Republic of
-
PLx PharmaCompletedDiabetes Mellitus, Type 2United States
-
BayerCompleted