Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
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
2 other identifiers
interventional
77
1 country
2
Brief Summary
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
Shorter than P25 for phase_2
2 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
June 4, 2010
CompletedFirst Posted
Study publicly available on registry
June 8, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
April 11, 2016
CompletedApril 11, 2016
March 1, 2016
5 months
June 4, 2010
June 22, 2015
March 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
15 days
Study Arms (2)
PL3100
EXPERIMENTALNaproxen
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male and female healthy adult subjects
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Houston Center For Clinical Research
Houston, Texas, 77074, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ronald Zimmerman, CEO & President
- Organization
- PLx Pharma LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2010
First Posted
June 8, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
April 11, 2016
Results First Posted
April 11, 2016
Record last verified: 2016-03