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

PLx Pharma

Status and phase: Completed; Phase 2

Conditions: Gastroduodenal Ulceration

Treatments: Drug: PL2200; Drug: Aspirin tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01646814

PL-ASA-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 247 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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247 participants in 2 patient groups

PL2200

Experimental group

Description:

Investigational product, PL2200

Treatment:

Drug: PL2200

Aspirin tablets

Active Comparator group

Description:

Active comparator, 325 mg aspirin tablets

Treatment:

Drug: Aspirin tablets