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Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

NCT01646814•PLx Pharma

View on ClinicalTrials.gov

Summary

This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.

Detailed Description

Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.

Eligibility

Age

50 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy volunteers, ≥50 and ≤75 years of age.
•No endoscopically observed baseline gastrointestinal lesions.

Exclusion Criteria

•Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters deemed clinically significant by the Investigator.
•Significant history of substance abuse or uncontrolled acute or chronic medical illness.
•Active H. pylori infection.
•Current use of low-dose aspirin for cardioprevention, or other ulcerogenic medications, gastroprotective, or anti-platelet agents.
•Hypersensitivity to aspirin or other NSAIDs.

Locations (10)

Jupiter, Florida, United States

South Miami, Florida, United States

Towson, Maryland, United States

New York, New York, United States

High Point, North Carolina, United States

Raleigh, North Carolina, United States

Dallas, Texas, United States

Houston, Texas, United States

San Antonio, Texas, United States

Chesapeake, Virginia, United States

Key Dates

Start Date

September 1, 2012

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

June 7, 2022

Enrollment

247

ACTUAL participants

Conditions

Gastroduodenal Ulceration

Interventions

PL2200

DRUG

Aspirin tablets

DRUG

Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

NCT01139190

Gastroduodenal UlcerationsErosion

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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