Phase 2
Completed N=77
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
Gastroduodenal Ulcerations · Erosion
Source: ClinicalTrials.gov NCT01139190 ↗
Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: Degree of GI Injury at Day 15 — 23; 20; 11; 13 participants
Summary
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of GI Injury at Day 15 |
23; 20; 11; 13 | — |
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.
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. Informational only — not medical advice.