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Therapeutic Areas: Gastroenterology | Hepatology (Liver, Pancreatic, Gall Bladder) | Family Medicine
Disease Category: Gastric Ulcers
Location: United States, TN

Clinical Trial Details

Overview

Research Study Summary

Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Asprin 325 mg in Subjects who are at risk for Developing Aspirin-Associated Ulcers

Purpose

This is a 6-Month study to evaluate the incidence of gastric ulcers after an investigational study drug compared to using coated Aspirin 325 mg in people who are at risk for developing aspirin associated ulcers. To participate, you must be curently taking 325 mg aspirin for at least 6 months for the secondary prevention of cardiovascular events and be >60 yrs old or be between 18-60 yrs old and have a history of a gastic ulcer in the past 5 years. The study requires 6 visits and 4 upper endoscopy tests and lasts 6 months. All study drug, procedures, labs are provided at no cost. Once you speak with a member of our staff, you will find out more details on this study and further assessment can be made to determine your eligibility. You will be compensated for your time and travel.

Patient Inclusion Criteria:

  • Must be male or non pregnant female who have been on daily aspirin 325mg for at least three months and are 55 years of age and older, or 18-54 years of age and have a history of documented gastric or duodenal ulcer within the past five years
  • Use Aspirin as a secondary prevention of cardiovascular or cerebrovascular events
  • Have been diagnosed with or have a history of: Myocardial Infarction, Ischemic stroke, Transient Ischemic Attack, Angina (stable or unstable), Peripheral arterial disease, Atherosclerotic aortic disease, Carotid Artery disease, Coronary artery bypass graft, stent placement, or carotid endarterectomy

Patient Exclusion Criteria:

  • Have had revascularization procedure within the last six months
  • Have uncontrolled diabetes, hypertension, or thyroid disorder
  • Have unstable cardiovascular or cerebrovascular disease
  • Have Congestive Heart Failure
  • Have a history of serious GI event, such as bleeding, perforation, or obstruction
  • Have had GI surgery
  • Have severe liver dysfunction
  • Have blood coagulation disorder, including use of systemic anticoagulants such as warfarin or other vitamin K antagonists

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 to 60 Years

Overall Status

Recruiting

Duration

6 Months

Facility Type

N/A

Contact

Rhonda Bovine, APN, MSN, CCRP, Clinical Director
ClinSearch, LLC
6035 Shallowford Road Suite 109
Chattanooga, TN 37421
Phone: 423-698-4584
Fax: 423-698-4577

View Map

Research Center Information: ClinSearch, LLC

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 170277

Date Last Changed: July 23, 2013


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