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

Erosion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139190
• Other study ID #: PL-NAP-002
• Secondary ID: 1RC3AR059535-01
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2010
• Last updated: February 15, 2011
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2011
• Source: PLx Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Erosion
• Gastroduodenal Ulcerations
• Ulcer

Intervention

Drug:
• PL3100
Oral administration
• Naproxen
Oral administration

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas
United States	Houston Center For Clinical Research	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
PLx Pharma	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of GI injury at Day 15	Endoscopic evaluation	15 days	Yes