The Effects of Aspirin and Acetaminophen on the Stomach in Healthy Volunteers

Completed · Phase 4 · Has a placebo group

Conditions studied: Healthy

In brief

Aspirin is a medication commonly used to relieve minor pains. Aspirin has also been used to prevent heart attacks and strokes. Aspirin, however, can also cause damage to the stomach and/or intestinal lining leading to the development of erosions ("small sores") and/or ulcers ("large sores"). Erosions may cause bleeding ("bleeding ulcers") and/or perforations ("holes in the stomach"). Acetaminophen, often referred by the brand name, Tylenol, is also used to treat minor pains but is not commonly recognized to cause damage to the stomach lining. Many patients often take both of these medications together. While the effects on the stomach lining of each medication, when used alone, are known, the effects of both medications, when used together, are not. The purpose of this study is to show whether or not the collective effects of both aspirin and acetaminophen, when used together, increase the damage on the stomach lining when compared to either medication alone.

Key facts

Study ID

NCT00594867

Run by

University of Illinois at Chicago

People needed

94

Starts

2006-12-01

Expected to finish

2007-12-01

Last updated by the study team

2019-05-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Be a cooperative, healthy male or female between the ages of 18-75 inclusive.
• Have a physical examination which reveals no clinically significant abnormalities at the screening visit.
• Have fewer than 6 gastric or duodenal erosions visible on nasal endoscopy at Visit 2.
• If the subject is female and of childbearing potential, she has been using effective contraception since the last date of her menses, will continue to use effective contraception during the study period, is not breast-feeding or lactating at screening and has had a negative urine pregnancy test at screening. Women who have been post-menopausal for less than 2 years will also require a urine pregnancy test at screening.
• Have provided written informed consent prior for admission to this study.
• H. pylori negative serologic exam prior to baseline nasal EGD.

You may not qualify if…

• Active GI disease (e.g. IBD), or a history of GI ulcers or bleeding
• History of gastric or intestinal surgery
• Use of ASA, NSAIDs, coxibs, or acetaminophen at any dose within 2 weeks prior to the randomization visit of the study.
• Positive FOBT at baseline.
• Use of over-the-counter or prescription: sucralfate, antacids, H2-receptor antagonists, misoprostol, or proton pump inhibitors 4 weeks prior to enrollment and/or during the study
• A known allergy to the topical anesthetic, lidocaine.

Where it is running

• University of Illinois Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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