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

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	50 - 75
Updated:	4/21/2016
Start Date:	September 2012
End Date:	June 2013

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

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. 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.

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.

We found this trial at

sites

Clinical Trial Facility in Towson Maryland

Towson, Maryland 21204

from

Towson, MD