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

This study has been completed.
Sponsor:
Information provided by:
POZEN
ClinicalTrials.gov Identifier:
NCT00441519
First received: February 27, 2007
Last updated: January 9, 2009
Last verified: January 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: aspirin
Drug: omeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Investigator-Blinded, Stratified, Randomized, Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin

Resource links provided by NLM:


Further study details as provided by POZEN:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 80
Study Start Date: February 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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 81 mg enteric coated (EC) aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers.

Secondary: To evaluate the safety and gastrointestinal tolerability, including ulcerogenic potential, and the effect on gastric pH of PA 325.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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
  2. Subject is > 50 years of age inclusive at the time of dosing
  3. Subject does not currently smoke and has not smoked for at least 3 months
  4. The subject's physical status is within normal limits of age and consistent with observations at screening
  5. The subject's Body Mass Index (BMI) is between 20-30 kg/m2
  6. 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:

  1. History of hypersensitivity to omeprazole or to another proton-pump inhibitor
  2. 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
  3. Participation in any study of an investigational treatment in the 4 weeks before Day 1 dosing
  4. 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
  5. GI disorder or surgery leading to impaired drug absorption
  6. 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
  7. Schizophrenia or bipolar disorder
  8. Use of any concomitant medication not approved by the study physician during the washout period and during the study conduct
  9. Serious blood coagulation disorder, including use of systemic anticoagulants
  10. Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to dosing
  11. 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
  12. Baseline endoscopy showing any gastric or duodenal mucosal abnormality (hemorrhages, ulcers or erosions)
  13. Gastric pH > 3 at Day - 1 endoscopy
  14. Screening laboratory alanine transaminase (ALT) or aspartate transaminase (AST) value > 2 times the upper limit of normal
  15. Estimated creatinine clearance < 30 ml/min at screening
  16. Other than noted specifically, any screening laboratory value that is clinically significant in the investigator's opinion and would endanger a subject if he or she were to participate in the study
  17. History of hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infections, or demonstration of HIV antibodies
  18. 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
  19. Subjects who have previously been a screen failure in this study
  20. 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
  21. 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
  22. Positive illicit drug screen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441519

Locations
United States, North Carolina
POZEN
Chapel Hill, North Carolina, United States, 27517
Canada, Quebec
MDS Pharma Services
Montreal, Quebec, Canada, H4R2N6
Sponsors and Collaborators
POZEN
Investigators
Study Director: Judy Bryson, Pharm. D. POZEN
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00441519     History of Changes
Other Study ID Numbers: PA325-102
Study First Received: February 27, 2007
Last Updated: January 9, 2009
Health Authority: Canada: Health Canada

Keywords provided by POZEN:
Gastroprotective effects
Aspirin

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014