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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
247
PL2200, containing 325 mg aspirin active ingredient
325 mg aspirin tablets (USP)
Unnamed facility
Jupiter, Florida, United States
Unnamed facility
South Miami, Florida, United States
Unnamed facility
Towson, Maryland, United States
Unnamed facility
New York, New York, United States
Incidence of Gastroduodenal Ulcers
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
Time frame: 42 Days
Number of Subjects With Erosion and Ulcers
\>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy
Time frame: 42 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
High Point, North Carolina, United States
Unnamed facility
Raleigh, North Carolina, United States
Unnamed facility
Dallas, Texas, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
San Antonio, Texas, United States
Unnamed facility
Chesapeake, Virginia, United States