Phase 2 N=77 Randomized Double-blind Prevention

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

Gastroduodenal Ulcerations · Erosion

Bottom Line

View on ClinicalTrials.gov: NCT01139190 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Degree of GI Injury at Day 15 — 23; 20; 11; 13 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PL3100 (Drug); Naproxen (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: PLx Pharma
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Degree of GI Injury at Day 15	23; 20; 11; 13	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01139190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.