Status:
COMPLETED
Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
Lead Sponsor:
PLx Pharma
Conditions:
Upper Gastrointestinal Mucosal Damage
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Subject is ≥50 to ≤75 years of age.
- Subject is healthy.
- Subject has a BMI between 20 and 32
- If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.
Exclusion
- Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
- Subject has an active Helicobacter pylori infection.
- Subject has a prior GI ulcer, bleeding, obstruction or perforation.
- Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
- Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
- Subject has used an investigational agent within the past 30 days.
- Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00872534
Start Date
January 1 2009
End Date
July 1 2009
Last Update
August 11 2015
Active Locations (6)
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1
Jupiter Research
Jupiter, Florida, United States
2
Miami Research Associates
South Miami, Florida, United States
3
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
4
Altoona Arthritis and Osteoporosis Center
Altoona, Pennsylvania, United States