Phase 2
N=247
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Gastroduodenal Ulceration
Bottom Line
View on ClinicalTrials.gov: NCT01646814 ↗Enrolled (actual)
247
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Incidence of Gastroduodenal Ulcers — 28; 34 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PL2200 (Drug); Aspirin tablets (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- PLx Pharma
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Gastroduodenal Ulcers |
28; 34 | — |
| SECONDARY Number of Subjects With Erosion and Ulcers |
56; 76 | 0.019 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01646814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.