Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
POZEN
ClinicalTrials.gov Identifier:
NCT00995410
First received: October 13, 2009
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

This study uses an open-label design and will be conducted in approximately 40 sites in the United States. Approximately 400 subjects will be enrolled in the study to ensure that approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects will have 12 months exposure to PA32540.


Condition Intervention Phase
Aspirin-Associated Gastric Ulcers
Drug: PA32540
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12-Month, Phase 3, Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers

Resource links provided by NLM:


Further study details as provided by POZEN:

Primary Outcome Measures:
  • To evaluate the long-term safety of PA32540 in subjects at risk for developing aspirin-associated gastric ulcers. A subject is considered to have completed the study if they complete 12 months of therapy and all scheduled assessments. [ Time Frame: Subjects will return at 1, 6, and 12 months for safety assessments ] [ Designated as safety issue: Yes ]

Enrollment: 380
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 325 mg enteric coated (EC) ASA and 40 mg omeprazole
PA32540 tablet
Drug: PA32540
PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole, PA32540 to be taken by mouth once daily

Detailed Description:

PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers. This study is designed to provide long-term safety data for PA32540 in order to gain regulatory approval to make PA32540 available for clinical use in this subject population.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. A. Male or non-pregnant, non-breastfeeding females who have been on daily aspirin 325 mg for at least three months and who are expected to use daily aspirin 325 mg for at least six months (Daily is defined as "at least 5 days per week"):

    AND, who are

    • 55 years of age and older; or
    • 18 - 54 years of age and have a history of a documented gastric or duodenal ulcer within the past five years.
  2. A. Aspirin use should be for the secondary prevention of cardiovascular or cerebrovascular events as defined as follows:

    Have been diagnosed with or have had a history of

    • MI (myocardial infarction that has been confirmed or suspected)
    • Ischemic stroke
    • TIA (transient ischemic attack)

    Or have established, clinically significant coronary and other atherosclerotic vascular disease (meaning at high risk for surgical intervention or for MI, TIA, stroke, if left untreated), including:

    • Angina (stable or unstable)
    • Peripheral arterial disease
    • Atherosclerotic aortic disease
    • Carotid artery disease Or have had
    • CABG (coronary artery bypass graft)
    • PCI (percutaneous coronary intervention with or without stent)
    • Carotid endarterectomy
  3. A. If female, subjects are eligible if they are of

    1. non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
    2. childbearing potential, have a negative pregnancy test at screening, and at least one of the following applies or is agreed to by the subject:

      • Female sterilization or sterilization of male partner
      • Hormonal contraception by oral route, implant, injectable, vaginal ring
      • 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)
      • Any other method with published data showing that the lowest expected failure rate is less than 1% per year 4. Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed

Exclusion criteria:

  1. Any current gastric, esophageal or duodenal ulcer
  2. Positive test result for H. pylori at screening 3A. Have had a revascularization procedure (i.e., Coronary Artery Bypass Graft, Percutaneous Transluminal Coronary Angioplasty, or carotid endarterectomy) less than six months prior to screening

4. Unstable hypertension as judged by the Investigator 5. Uncontrolled diabetes mellitus as judged by the Investigator 6. Unstable cardio- or cerebrovascular disease such that it would endanger the subject if they participated in the trial 7. Clinically significant valvular disease 8. Congestive heart failure or other cardiovascular symptoms according to New York Heart Association (NYHA) Functional Classification III-IV (Appendix 3) 9. History of hypersensitivity to omeprazole or to another proton pump inhibitor 10. History of allergic reaction or intolerance to aspirin and/or a history of aspirin-induced symptoms of asthma, rhinitis, and/or nasal polyps 11. History of serious UGI event, such as bleeding, perforation, or obstruction 12. Gastrointestinal disorder or surgery leading to impaired drug absorption 13. Presence of chronic or uncontrolled acute medical illness, e.g. gastrointestinal disorder (esophageal stricture, severe esophagitis, long-segment Barrett's esophagus, signs and symptoms of gastric outlet obstruction), thyroid disorder and/or infection that would endanger a subject if they were to participate in the study 14. Schizophrenia, uncontrolled bipolar disorder, or severe depression 15. History of alcoholism or drug addiction within a year prior to enrollment in the study 16. Severe hepatic dysfunction (i.e. cirrhosis or portal hypertension) 17. Blood coagulation disorder, including use of systemic anticoagulants such as warfarin or other vitamin K antagonists 18. Any condition that, in the opinion of the Investigator, may either put the subject at risk or influence the results of the study 19. Use of any excluded concomitant medication (see Section 9.2) 20. Screening laboratory ALT or AST value > two times the upper limit of normal 21A. History of renal insufficiency 22. Other than noted specifically, any screening laboratory value that is clinically significant in the Investigator's opinion and would endanger a subject if the subject was to participate in the study 23. Use of an investigational treatment in the 4 weeks before screening 24. History of malignancy, treated or untreated, within the past five years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin 25. Previous participation in another PA32540 clinical research study 26. Subjects, who are employees of the research facility, immediately related to the Investigator, or are in some way under the supervision of the Investigator.

  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: NCT00995410

Locations
United States, North Carolina
Pozen
Chapel Hill, North Carolina, United States, 27519
Sponsors and Collaborators
POZEN
  More Information

Additional Information:
No publications provided

Responsible Party: POZEN
ClinicalTrials.gov Identifier: NCT00995410     History of Changes
Other Study ID Numbers: PA32540-303
Study First Received: October 13, 2009
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by POZEN:
Subjects Who are at Risk for Developing Aspirin-ASA
Subject must have a pre-existing condition for which aspirin is already indicated
Gastric Ulcers

Additional relevant MeSH terms:
Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
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 July 24, 2014