To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin

NCT00442052 | Completed Phase 1 DMC

• 1 other identifier: PA325-101
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

Primary: 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.

Conditions

Healthy

Keywords

Gastroprotective effects; Aspirin

Outcome Measures

Primary Outcomes (1)

• To compare the gastroprotective effects of a once-daily dose of PA 325

Secondary Outcomes (1)

• To evaluate the safety and GI tolerability including ulcerogenic potential, the pharmacokinetic profile, and the effect on gastric pH of PA 325

Interventions

aspirin DRUG

omeprazole DRUG

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• mL of blood in 14 days;
• ,500 mL of blood in 180 days;
• ,500 mL of blood in 1 year.
• Baseline endoscopy showing any gastric or duodenal mucosal abnormality (hemorrhages, ulcers or erosions)

Sponsors & Collaborators

• POZEN: lead

Study Sites (2)

POZEN

Chapel Hill, North Carolina, 27517, United States

Location

MDS Pharma Services

Montreal, Quebec, H4R2N6, Canada

Location

MeSH Terms

Interventions

Aspirin; Omeprazole

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gaetano Morelli, MD

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: November 1, 2006
• Study Completion: January 1, 2007
• Last Updated: March 1, 2007

Record last verified: 2007-02

Locations

US (1); CA (1)