Back to resultsEvaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Primary Purpose
Gastroduodenal Ulceration
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PL2200
Aspirin tablets
Sponsored by
About this trial
This is an interventional treatment trial for Gastroduodenal Ulceration focused on measuring Healthy volunteer, comparison of incidence of, treatment groups.
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers, ≥50 and ≤75 years of age.
- No endoscopically observed baseline gastrointestinal lesions.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PL2200
Aspirin tablets
Arm Description
Investigational product, PL2200
Active comparator, 325 mg aspirin tablets
Outcomes
Primary Outcome Measures
Incidence of Gastroduodenal Ulcers
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
Secondary Outcome Measures
Number of Subjects With Erosion and Ulcers
>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01646814
Brief Title
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Official Title
A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PLx Pharma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroduodenal Ulceration
Keywords
Healthy volunteer, comparison of incidence of, treatment groups.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
247 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PL2200
Arm Type
Experimental
Arm Description
Investigational product, PL2200
Arm Title
Aspirin tablets
Arm Type
Active Comparator
Arm Description
Active comparator, 325 mg aspirin tablets
Intervention Type
Drug
Intervention Name(s)
PL2200
Other Intervention Name(s)
PL-ASA
Intervention Description
PL2200, containing 325 mg aspirin active ingredient
Intervention Type
Drug
Intervention Name(s)
Aspirin tablets
Intervention Description
325 mg aspirin tablets (USP)
Primary Outcome Measure Information:
Title
Incidence of Gastroduodenal Ulcers
Description
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
Time Frame
42 Days
Secondary Outcome Measure Information:
Title
Number of Subjects With Erosion and Ulcers
Description
>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy
Time Frame
42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers, ≥50 and ≤75 years of age.
No endoscopically observed baseline gastrointestinal lesions.
Exclusion Criteria:
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.
Facility Information:
City
Jupiter
State/Province
Florida
Country
United States
City
South Miami
State/Province
Florida
Country
United States
City
Towson
State/Province
Maryland
Country
United States
City
New York
State/Province
New York
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Chesapeake
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
We'll reach out to this number within 24 hrs