A Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers

NCT00961350 | Completed Phase 3 Results DMC

• 1 other identifier: PA32540-301
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief Summary

Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.

Conditions

Gastric Ulcer

Keywords

PA32540 is proposed for the secondary prevention of cardio- and cerebrovascular events in patients at risk for developing aspirin-associated gastric ulcers.

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Gastric Ulcer Confirmed by Endoscopy(EC) Aspirin 325 mg

  The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.

  6 months

Secondary Outcomes (4)

• The Number of Participants With Gastric and/or Duodenal Ulcers

  6 Months

• The Number of Subjects With "Treatment Success"

  6 Months

• The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events

  6 months

• The Number of Participants With Heartburn Resolution at 6 Months, ie no Heartburn Symptoms During the Last 7 Days Prior to the Visit

  6 Months

Study Arms (2)

PA32540

EXPERIMENTAL

PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole

Drug: PA32540

EC Aspirin

ACTIVE COMPARATOR

The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)

Drug: EC Aspirin 325

Interventions

PA32540 DRUG

PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole

Also known as: YOSPRALA

PA32540

EC Aspirin 325 DRUG

The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)

EC Aspirin

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age and older; or
• years of age and have a history of a documented gastric or duodenal ulcer within the past five years.
• 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)

You may not qualify if:

• Baseline endoscopy showing any gastric, esophageal or duodenal ulcer at least 3 mm in diameter with depth
• 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
• \. 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 or 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 Principal Investigator, or are in some way under the supervision of the Principal Investigator.

Sponsors & Collaborators

• POZEN: lead

Study Sites (1)

Pozen

Chapel Hill, North Carolina, 27519, United States

Location

MeSH Terms

Conditions

Stomach Ulcer

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Results Point of Contact

• Title: John Fort, MD / Chief Medical Officer
• Organization: POZEN

jfort@pozen.com

919-913-1030

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2009
• First Posted: August 18, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 18, 2016
• Results First Posted: January 21, 2016

Record last verified: 2016-01

Locations

US (1)