NCT01139190

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

A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: PLx Pharma · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Gastroduodenal Ulcerations
• Erosion

Interventions

Type	Name	Description
DRUG	PL3100	Oral administration
DRUG	Naproxen	Oral administration

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-06-08
• Last updated: 2016-04-11
• Results posted: 2016-04-11

Locations

2 sites across 1 country: United States