Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
- Registration Number
- NCT01646814
- Lead Sponsor
- PLx Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 247
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PL2200 PL2200 Investigational product, PL2200 Aspirin tablets Aspirin tablets Active comparator, 325 mg aspirin tablets
- Primary Outcome Measures
Name Time Method Incidence of Gastroduodenal Ulcers 42 Days Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
- Secondary Outcome Measures
Name Time Method Number of Subjects With Erosion and Ulcers 42 days \>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy