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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PL-2200 | Experimental | PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix. |
|
| Aspirin | Active Comparator | Immediate release 325mg aspirin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetylsalicylic acid | Drug | 325mg once a day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After 7 days of study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byron L Cryer, MD | Dallas VA | Principal Investigator |
| Frank L Lanza, MD | Houston Institute for Clinical Research | Principal Investigator |
| Michael E Schwartz, DO | Jupiter Research | Principal Investigator |
| Alan J Kivitz, MD | Altoona Arthritis and Osteoporosis Center | Principal Investigator |
| Phillip B Miner, MD | Oklahoma Foundation for Digestive Research | Principal Investigator |
| Howard Schwartz, MD | Miami Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jupiter Research | Jupiter | Florida | United States | |||
| Miami Research Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Aspirin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Aspirin | Immediate release 325mg aspirin acetylsalicylic acid: 325mg once a day for 7 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | After 7 days of study medication |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 100 | 8 | 100 | ||
| EG001 | Aspirin | Immediate release 325mg aspirin acetylsalicylic acid: 325mg once a day for 7 days | 0 | 104 | 14 | 104 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders |
| |||
| Stomach Ulcer | Gastrointestinal disorders |
|
Standard Confidentiality Agreement
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ronald Zimmerman, CEO & President | PLx Pharma | 1-713-842-1249 | 205 | ron.zimmerman@plxpharma.com |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Male |
|