Back to resultsClinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
Primary Purpose
Gastroduodenal Ulcerations, Erosion
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PL3100
Naproxen
Sponsored by
About this trial
This is an interventional prevention trial for Gastroduodenal Ulcerations focused on measuring NSAID-induced gastroduodenal ulcerations or erosion
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.
Sites / Locations
- Dallas VA Medical Center
- Houston Center For Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PL3100
Naproxen
Arm Description
Outcomes
Primary Outcome Measures
Degree of GI Injury at Day 15
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01139190
First Posted
June 4, 2010
Last Updated
March 28, 2016
Sponsor
PLx Pharma
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT01139190
Brief Title
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
Official Title
A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PLx Pharma
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroduodenal Ulcerations, Erosion
Keywords
NSAID-induced gastroduodenal ulcerations or erosion
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PL3100
Arm Type
Experimental
Arm Title
Naproxen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PL3100
Intervention Description
Oral administration
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Degree of GI Injury at Day 15
Description
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
Time Frame
15 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 (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.
Facility Information:
Facility Name
Dallas VA Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Houston Center For Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
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