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NCT01646814 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
A Phase 2 study of Gastroduodenal Ulceration, sponsored by PLx Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 247
- Enrollment target
- 10
- Study locations
NCT01646814: Completed Phase 2 study of Gastroduodenal Ulceration, sponsored by PLx Pharma.
NCT01646814 is a Phase 2 study of Gastroduodenal Ulceration that has completed, run by PLx Pharma. The registered enrollment target is 247 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01646814, a Phase 2 study of Gastroduodenal Ulceration, has completed, sponsored by PLx Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 247 participants
- Enrollment target
- 10
- Study locations
Study Summary
This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.
Primary Outcome
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
Conditions Studied
Interventions
- DRUG PL2200
- DRUG Aspirin tablets
Study Locations (10)
Texas
- - Dallas
- - Houston
- - San Antonio
Florida
- - Jupiter
- - South Miami
North Carolina
- - High Point
- - Raleigh
Maryland
- - Towson
New York
- - New York
Virginia
- - Chesapeake
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01646814 record still lists
NCT01646814 is an interventional study that assigns participants to a tested intervention. The registered 247 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% higher).
The record links to 1 condition, with Gastroduodenal Ulceration appearing as the primary indexed condition, and to 2 interventions - of which PL2200 is the first listed.
NCT01646814 lists 10 locations in 6 states (Texas, Florida, North Carolina).
Frequently Asked Questions
What is clinical trial NCT01646814 about?
NCT01646814 is a clinical study titled "Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects". This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.
What is the current status of trial NCT01646814?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2012-09. Estimated completion is 2013-06.
What conditions does trial NCT01646814 study?
This clinical trial studies the following conditions: Gastroduodenal Ulceration.
What interventions are being tested in trial NCT01646814?
The interventions under investigation include: PL2200 (DRUG), Aspirin tablets (DRUG).
Who is sponsoring clinical trial NCT01646814?
This trial is sponsored by PLx Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01646814 being conducted?
This trial has 10 study locations across Florida, Maryland, New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01646814's enrollment target sits among peer trials
247 234th of 2000 higher than 1,767 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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