Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 50 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | September 2012 |
| End Date: | June 2013 |
A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
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. 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.
injury after the oral administration of an investigational product, PL2200, and a marketed
325 mg immediate-release aspirin product. 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.
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.
We found this trial at
10
sites
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