Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers

Completed · Phase 1/Phase 2

Conditions studied: Upper Gastrointestinal Mucosal Damage

In brief

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.

Key facts

Study ID

NCT00872534

Run by

PLx Pharma

People needed

204

Starts

2009-01-01

Expected to finish

2009-07-01

Last updated by the study team

2015-08-11

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Dallas VA Medical Center — Dallas, Texas, United States
• Houston Center For Clinical Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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