Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers

A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers

To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Mucosal Damage
• Intervention / Treatment: Drug: acetylsalicylic acid

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jupiter, Florida, United States
      • Jupiter Research
    • South Miami, Florida, United States
      • Miami Research Associates
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Oklahoma Foundation for Digestive Research
  • Pennsylvania
    • Altoona, Pennsylvania, United States
      • Altoona Arthritis and Osteoporosis Center
  • Texas
    • Dallas, Texas, United States
      • Dallas VA Medical Center
    • Houston, Texas, United States
      • Houston Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is ≥50 to ≤75 years of age.
• Subject is healthy.
• Subject has a BMI between 20 and 32
• If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.

Exclusion Criteria:

• Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
• Subject has an active Helicobacter pylori infection.
• Subject has a prior GI ulcer, bleeding, obstruction or perforation.
• Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
• Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
• Subject has used an investigational agent within the past 30 days.
• Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PL-2200; PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.	Drug: acetylsalicylic acid; 325mg once a day for 7 days
ACTIVE_COMPARATOR: Aspirin; Immediate release 325mg aspirin	Drug: acetylsalicylic acid; 325mg once a day for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Subjects With Gastroduodenal Erosions and Ulcers.	Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).	After 7 days of study medication

Collaborators and Investigators

• Sponsor: PLx Pharma
• Investigators: Principal Investigator: Byron L Cryer, MD, Dallas VA; Principal Investigator: Frank L Lanza, MD, Houston Institute For Clinical Research; Principal Investigator: Michael E Schwartz, DO, Jupiter Research; Principal Investigator: Alan J Kivitz, MD, Altoona Arthritis and Osteoporosis Center; Principal Investigator: Phillip B Miner, MD, Oklahoma Foundation for Digestive Research; Principal Investigator: Howard Schwartz, MD, Miami Research Associates

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2009

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 30, 2009
• First Posted (ESTIMATE): March 31, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2015
• Last Update Submitted That Met QC Criteria: August 5, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: To evaluate the acute gastrointestinal safety of PL-2100.
• Additional Relevant MeSH Terms: 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-002