Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
NCT ID: NCT00872534
Last Updated: 2015-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
204 participants
INTERVENTIONAL
2009-01-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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PL-2200
PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid
325mg once a day for 7 days
Aspirin
Immediate release 325mg aspirin
acetylsalicylic acid
325mg once a day for 7 days
Interventions
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acetylsalicylic acid
325mg once a day for 7 days
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
50 Years
75 Years
ALL
Yes
Sponsors
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PLx Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Byron L Cryer, MD
Role: PRINCIPAL_INVESTIGATOR
Dallas VA
Frank L Lanza, MD
Role: PRINCIPAL_INVESTIGATOR
Houston Institute for Clinical Research
Michael E Schwartz, DO
Role: PRINCIPAL_INVESTIGATOR
Jupiter Research
Alan J Kivitz, MD
Role: PRINCIPAL_INVESTIGATOR
Altoona Arthritis and Osteoporosis Center
Phillip B Miner, MD
Role: PRINCIPAL_INVESTIGATOR
Oklahoma Foundation for Digestive Research
Howard Schwartz, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Research Associates
Locations
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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
Countries
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Other Identifiers
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PL-ASA-002
Identifier Type: -
Identifier Source: org_study_id
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