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

Phase 2

Completed

• Conditions: Erosion; Gastroduodenal Ulcerations
• Interventions: Drug: PL3100; Drug: Naproxen

• Registration Number: NCT01139190
• Lead Sponsor: PLx Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Study Start: 2010-07
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2015-06-22
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-28
• Last Update Submitted: 2016-03-28
• Results First Posted: 2016-04-11
• Last Update Posted: 2016-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PL3100	PL3100	-
Naproxen	Naproxen	-

Primary Outcome Measures

Name	Time	Method
Degree of GI Injury at Day 15	15 days	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

Trial Locations

Locations (2)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States

Houston Center For Clinical Research; 🇺🇸 Houston, Texas, United States