Gastroduodenal Ulceration
Conditions
Keywords
Healthy volunteer, comparison of incidence of, treatment groups.
Brief summary
This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.
Detailed description
Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.
Interventions
DRUGPL2200
PL2200, containing 325 mg aspirin active ingredient
DRUGAspirin tablets
325 mg aspirin tablets (USP)
Sponsors
PLx Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers, ≥50 and ≤75 years of age. * No endoscopically observed baseline gastrointestinal lesions.
Exclusion criteria
* Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters deemed clinically significant by the Investigator. * Significant history of substance abuse or uncontrolled acute or chronic medical illness. * Active H. pylori infection. * Current use of low-dose aspirin for cardioprevention, or other ulcerogenic medications, gastroprotective, or anti-platelet agents. * Hypersensitivity to aspirin or other NSAIDs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Gastroduodenal Ulcers | 42 Days | Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Erosion and Ulcers | 42 days | \>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PL2200 Investigational product, PL2200
PL2200: PL2200, containing 325 mg aspirin active ingredient | 121 |
| Aspirin Tablets Active comparator, 325 mg aspirin tablets
Aspirin tablets: 325 mg aspirin tablets (USP) | 126 |
| Total | 247 |
Baseline characteristics
| Characteristic | PL2200 | Aspirin Tablets | Total |
|---|---|---|---|
| Age, Customized ≥ 50 and ≤ 75 years | 121 participants | 126 participants | 247 participants |
| Sex: Female, Male Female | 71 Participants | 82 Participants | 153 Participants |
| Sex: Female, Male Male | 50 Participants | 44 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 60 / 121 | 68 / 126 |
| serious Total, serious adverse events | 0 / 121 | 0 / 126 |
Outcome results
Primary
Incidence of Gastroduodenal Ulcers
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
Time frame: 42 Days
Population: Per protocol population (ie, Treated with ≥1 dose and Day 7 dose administered and endoscopy performed and ≥85% compliant)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PL2200 | Incidence of Gastroduodenal Ulcers | 28 participants |
| Aspirin Tablets | Incidence of Gastroduodenal Ulcers | 34 participants |
Secondary
Number of Subjects With Erosion and Ulcers
\>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy
Time frame: 42 days
Population: Full analysis set population, as randomized. Subjects treated with at least one dose of study drug and day 7 endoscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PL2200 | Number of Subjects With Erosion and Ulcers | 56 Participants |
| Aspirin Tablets | Number of Subjects With Erosion and Ulcers | 76 Participants |
p-value: 0.019Chi-squared