To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
204
325mg once a day for 7 days
Jupiter Research
Jupiter, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Altoona Arthritis and Osteoporosis Center
Altoona, Pennsylvania, United States
Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
Incidence of subjects with gastroduodenal composite scores of 3 or 4 (\> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).
Time frame: After 7 days of study medication
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Dallas VA Medical Center
Dallas, Texas, United States
Houston Center For Clinical Research
Houston, Texas, United States