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NCT01139190 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
A Phase 2 study, sponsored by PLx Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT01139190: Completed Phase 2 study, sponsored by PLx Pharma.
NCT01139190 is a Phase 2 study that has completed, run by PLx Pharma. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01139190, a Phase 2 study, has completed, sponsored by PLx Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
Primary Outcome
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
Interventions
- DRUG Naproxen
- DRUG PL3100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2010-07 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
What the finished NCT01139190 record still lists
NCT01139190 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Naproxen is the first listed.
NCT01139190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01139190 about?
NCT01139190 is a clinical study titled "Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults". The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
What is the current status of trial NCT01139190?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2010-07. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01139190?
The interventions under investigation include: Naproxen (DRUG), PL3100 (DRUG).
Who is sponsoring clinical trial NCT01139190?
This trial is sponsored by PLx Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01139190's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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