NCT01646814

Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: PLx Pharma · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastroduodenal Ulceration

Interventions

Type	Name	Description
DRUG	PL2200	PL2200, containing 325 mg aspirin active ingredient
DRUG	Aspirin tablets	325 mg aspirin tablets (USP)

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-07-20
• Last updated: 2022-06-07
• Results posted: 2015-10-05

Locations

10 sites across 1 country: United States