Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
1 other identifier
interventional
247
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2012
CompletedFirst Posted
Study publicly available on registry
July 20, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
October 5, 2015
CompletedJune 7, 2022
May 1, 2022
9 months
July 18, 2012
June 18, 2015
May 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Gastroduodenal Ulcers
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
42 Days
Secondary Outcomes (1)
Number of Subjects With Erosion and Ulcers
42 days
Study Arms (2)
PL2200
EXPERIMENTALInvestigational product, PL2200
Aspirin tablets
ACTIVE COMPARATORActive comparator, 325 mg aspirin tablets
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers, ≥50 and ≤75 years of age.
- No endoscopically observed baseline gastrointestinal lesions.
You may not qualify if:
- Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters deemed clinically significant by the Investigator.
- Significant history of substance abuse or uncontrolled acute or chronic medical illness.
- Active H. pylori infection.
- Current use of low-dose aspirin for cardioprevention, or other ulcerogenic medications, gastroprotective, or anti-platelet agents.
- Hypersensitivity to aspirin or other NSAIDs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PLx Pharmalead
Study Sites (10)
Unknown Facility
Jupiter, Florida, United States
Unknown Facility
South Miami, Florida, United States
Unknown Facility
Towson, Maryland, United States
Unknown Facility
New York, New York, United States
Unknown Facility
High Point, North Carolina, United States
Unknown Facility
Raleigh, North Carolina, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Chesapeake, Virginia, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Regulatory Affairs Director
- Organization
- PLxPharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2012
First Posted
July 20, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 7, 2022
Results First Posted
October 5, 2015
Record last verified: 2022-05