A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin

NCT00441519 | Completed Phase 1 DMC

• 1 other identifier: PA325-102
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

Gastroprotective effects; Aspirin

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the occurrence of gastric and/or duodenal bulb lesions meeting Grade 3 or Grade 4 Lanza (1988) scores for the stomach and duodenal bulb (combined).

Secondary Outcomes (1)

• Secondary endpoints include the incidence of gastric and/or duodenal ulcers, total number of gastric and/or duodenal erosions, gastric pH and any other GI tolerability issues.

Interventions

aspirin DRUG

omeprazole DRUG

Eligibility Criteria

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

You may qualify if:

• Subject is a male or a female who is not pregnant or is not lactating. A female is eligible to enter and participate in this study if she is of:
• Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
• Childbearing potential has a negative pregnancy test 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
• Subject is \> 50 years of age inclusive at the time of dosing
• Subject does not currently smoke and has not smoked for at least 3 months
• The subject's physical status is within normal limits of age and consistent with observations at screening
• The subject's Body Mass Index (BMI) is between 20-30 kg/m2
• 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 NSAID and/or 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. GI disorder, hypertension, diabetes, thyroid disorder, depression and/or infection that would endanger a subject if they were to participate in the study
• GI 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 he or she 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 Day - 1 endoscopy
• Screening laboratory alanine transaminase (ALT) or aspartate transaminase (AST) value \> 2 times the upper limit of normal
• Estimated creatinine clearance \< 30 ml/min at screening

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

• Judy Bryson, Pharm. D.

  POZEN

  STUDY DIRECTOR

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: February 1, 2007
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: January 12, 2009

Record last verified: 2009-01

Locations

US (1); CA (1)