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

NCT00594867 | Completed Phase 4

• 1 other identifier: 2006-0459
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy; Volunteer

Outcome Measures

Primary Outcomes (1)

• Incidence of combined gastric and duodenal ulcers, defined as >1 gastric, pyloric channel or duodenal ulcer (score 7), as determined by nasal upper GI endoscopy on day 7 of treatment.

  7 days

Secondary Outcomes (1)

• Incidence of any gastric or duodenal ulcer (score 7) and any gastric and duodenal, gastric or duodenal erosions/ulcer (score 4-7) as determined by nasal upper endoscopy on day 7 of treatment.

  7 days

Study Arms (3)

1

ACTIVE COMPARATOR

Acetaminophen - 4 grams per day + Placebo

Drug: Acetaminophen - 4 grams per day + Placebo

2

ACTIVE COMPARATOR

Aspirin - 325 mg per day + Placebo

Drug: Aspirin - 325 mg per day + Placebo

3

EXPERIMENTAL

Acetaminophen 4 gram per day + Aspirin 325 mg per day

Drug: Acetaminophen 4 gram per day + Aspirin 325 mg per day

Interventions

Acetaminophen - 4 grams per day + Placebo DRUG

Acetaminophen - 4 grams per day + Placebo

1

Aspirin - 325 mg per day + Placebo DRUG

Aspirin - 325 mg per day + Placebo

2

Acetaminophen 4 gram per day + Aspirin 325 mg per day DRUG

Acetaminophen 4 gram per day + Aspirin 325 mg per day

3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (9)

• Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71.

  PMID: 11786451 BACKGROUND

• Patrono C, Garcia Rodriguez LA, Landolfi R, Baigent C. Low-dose aspirin for the prevention of atherothrombosis. N Engl J Med. 2005 Dec 1;353(22):2373-83. doi: 10.1056/NEJMra052717. No abstract available.

  PMID: 16319386 BACKGROUND

• Weil J, Colin-Jones D, Langman M, Lawson D, Logan R, Murphy M, Rawlins M, Vessey M, Wainwright P. Prophylactic aspirin and risk of peptic ulcer bleeding. BMJ. 1995 Apr 1;310(6983):827-30. doi: 10.1136/bmj.310.6983.827.

  PMID: 7711618 BACKGROUND

• Derry S, Loke YK. Risk of gastrointestinal haemorrhage with long term use of aspirin: meta-analysis. BMJ. 2000 Nov 11;321(7270):1183-7. doi: 10.1136/bmj.321.7270.1183.

  PMID: 11073508 BACKGROUND

• Goldstein JL, Lowry SC, Lanza FL, Schwartz HI, Dodge WE. The impact of low-dose aspirin on endoscopic gastric and duodenal ulcer rates in users of a non-selective non-steroidal anti-inflammatory drug or a cyclo-oxygenase-2-selective inhibitor. Aliment Pharmacol Ther. 2006 May 15;23(10):1489-98. doi: 10.1111/j.1365-2036.2006.02912.x.

  PMID: 16669964 BACKGROUND

• Sorensen HT, Mellemkjaer L, Blot WJ, Nielsen GL, Steffensen FH, McLaughlin JK, Olsen JH. Risk of upper gastrointestinal bleeding associated with use of low-dose aspirin. Am J Gastroenterol. 2000 Sep;95(9):2218-24. doi: 10.1111/j.1572-0241.2000.02248.x.

  PMID: 11007221 BACKGROUND

• Cryer B, Feldman M. Cyclooxygenase-1 and cyclooxygenase-2 selectivity of widely used nonsteroidal anti-inflammatory drugs. Am J Med. 1998 May;104(5):413-21. doi: 10.1016/s0002-9343(98)00091-6.

  PMID: 9626023 BACKGROUND

• Lanza FL, Codispoti JR, Nelson EB. An endoscopic comparison of gastroduodenal injury with over-the-counter doses of ketoprofen and acetaminophen. Am J Gastroenterol. 1998 Jul;93(7):1051-4. doi: 10.1111/j.1572-0241.1998.00327.x.

  PMID: 9672328 BACKGROUND

• Jick H. Effects of aspirin and acetaminophen in gastrointestinal hemorrhage. Results from the Boston Collaborative Drug Surveillance Program. Arch Intern Med. 1981 Feb 23;141(3 Spec No):316-21. doi: 10.1001/archinte.141.3.316.

  PMID: 6970559 BACKGROUND

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jay L Goldstein, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 16, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

US (1)