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

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.

Study Overview

• Status: Completed
• Conditions: Gastroduodenal Ulceration
• Intervention / Treatment: Drug: PL2200; Drug: Aspirin tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jupiter, Florida, United States
    • South Miami, Florida, United States
  • Maryland
    • Towson, Maryland, United States
  • New York
    • New York, New York, United States
  • North Carolina
    • High Point, North Carolina, United States
    • Raleigh, North Carolina, United States
  • Texas
    • Dallas, Texas, United States
    • Houston, Texas, United States
    • San Antonio, Texas, United States
  • Virginia
    • Chesapeake, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PL2200; Investigational product, PL2200	Drug: PL2200; PL2200, containing 325 mg aspirin active ingredient; Other Names: PL-ASA
Active Comparator: Aspirin tablets; Active comparator, 325 mg aspirin tablets	Drug: Aspirin tablets; 325 mg aspirin tablets (USP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Gastroduodenal Ulcers	Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth	42 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Erosion and Ulcers	>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy	42 days

Collaborators and Investigators

• Sponsor: PLx Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Healthy volunteer; comparison of incidence of; treatment groups.
• Additional Relevant MeSH Terms: Pathologic Processes; Ulcer; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: PL-ASA-005