Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

PLx Pharma77 enrolled

Overview

The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Gastroduodenal Ulcerations Erosion

Interventions

PL3100DRUG

Oral administration

NaproxenDRUG

Oral administration

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria (Selected) * Male and female healthy adult subjects Exclusion Criteria (Selected) * Subject has protocol specified significant medical history. * Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study. * Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.

Locations (2)

Dallas VA Medical Center

Dallas, Texas, United States

Houston Center For Clinical Research

Houston, Texas, United States

Outcomes

Primary Outcomes

Degree of GI Injury at Day 15

Degree of mucosal injury was assessed by endoscopy, with the following scoring system: Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: \> 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: \> 10 erosions and/or an ulcer

Time frame: 15 days

Data from ClinicalTrials.gov

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