A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2004-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding properties and their effects on the stomach in healthy volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Trial of NSAID Dosing Strategies

NCT05239767

Musculoskeletal Pain Acute Pain

COMPLETED PHASE4

A Study of Channeling in the Use of Nonprescription Paracetamol and Ibuprofen in an Electronic Medical Records Database: Evidence and Implications

NCT02830178

Hemorrhage, Gastrointestinal Myocardial Infarction Stroke +1 more

COMPLETED

A Study to Assess Disintegration of the New Aspirin Disintegrating Tablets

NCT03225352

Moderate Pain

COMPLETED PHASE1

Perioperative Inflammation and Breast Cancer Outcome

NCT02141139

Breast Neoplasms

UNKNOWN PHASE3

Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers

NCT00945178

Healthy Volunteers

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this randomized, multiple-dose, single-blind, parallel-group study is to examine in healthy volunteers the effects of analgesics given in approved daily doses in addition to daily cardio-protective doses of aspirin (81 mg) on the stomach. All subjects are examined endoscopically before receiving study medication, and at the end of treatment on Day 9. Each subject takes 81 mg of aspirin daily plus one of the following treatments to be taken daily on Days 1 through 8: four doses of acetaminophen 1000 mg, three doses of ibuprofen 400 mg, two doses of naproxen sodium (440 mg in the morning and 220 mg in the evening), four doses of aspirin 650 mg, two doses of celecoxib 200 mg, one dose of rofecoxib 25 mg, or no additional study medication. On Day 9, one dose of aspirin 81 mg and only one dose of the assigned treatment drug are taken prior to having an endoscopy. The primary endpoints of the study are the effects of the analgesics on the inhibition of COX-1 activity by aspirin, and any injury to the stomach mucosa, as determined by direct endoscopic observation. Safety assessments consist of routine monitoring for adverse events, as well as endoscopic examination of gastric mucosa for erosions and ulcerations occurring during the treatment phase. The study hypothesis is that the effects of acetaminophen on the stomach do not differ from the effects of ibuprofen, naproxen, aspirin, celecoxib, or rofecoxib. 81 mg aspirin and 1of 7 treatments for 8 days: acetaminophen 1000mg 4xday, ibuprofen 400mg 3xday, naproxen 440mg morning and 220mg evening, no additional study medication, aspirin 650mg 4xday, celecoxib 200mg 2xday,rofecoxib 25mg 1xday. On Day 9, 1 dose aspirin \& 1 dose study drug before endoscopy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

aspirin, acetaminophen, ibuprofen, naproxen, celecoxib, rofecoxib

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* In general good health with normal hemostatic (blood coagulation) parameters
* able to swallow study medication
* non-smoker
* negative for H. pylori infection
* if female, must not be pregnant or breast feeding

Exclusion Criteria

* Have taken anti-inflammatory drugs within one week of study entry, any analgesic within 24 hours before baseline endoscopy, or systemic steroids within 6 weeks of study entry
* unable to tolerate oral drugs or have had gastrointestinal disease or prior gastrointestinal surgery that could interfere with the study medication
* unable to understand or follow instructions
* have a medical condition or clinically significant abnormal laboratory results that may be relevant to participation in the study

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes