Erosion, Gastroduodenal Ulcerations
Conditions
Keywords
NSAID-induced gastroduodenal ulcerations or erosion
Brief summary
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
Interventions
DRUGPL3100
Oral administration
DRUGNaproxen
Oral administration
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
PLx Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of GI Injury at Day 15 | 15 days | 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment initiated: 01 July 2010, Multicenter trial: Private practice setting and Veterans Administration gastroenterology clinic.
Pre-assignment details
No run-in period; subjects screened and enrolled based on review and confirmation of eligibility per inclusion/exclusion criteria. Wash-out period for NSAIDs and gastroprotective agents.
Participants by arm
| Arm | Count |
|---|---|
| PL3100 Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days. | 38 |
| Naproxen Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days. | 39 |
| Total | 77 |
Baseline characteristics
| Characteristic | PL3100 | Naproxen | Total |
|---|---|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 5.97 | 55.6 years STANDARD_DEVIATION 4.56 | 56.1 years STANDARD_DEVIATION 5.29 |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 16 Participants | 19 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 38 | 7 / 39 |
| serious Total, serious adverse events | 0 / 38 | 0 / 39 |
Outcome results
Primary
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
Time frame: 15 days
Population: Per Protocol Population: subset of participants who had an endoscopy performed at Day 15 reviewed by both blinded endoscopists, was at least 85% compliant with taking the study drug (based on pill counts), who took the final dose drug on the day of the second endoscopy, and who had no other protocol violations that would affect assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PL3100 | Degree of GI Injury at Day 15 | Gastroduodenal Score of 3 or Higher | 23 participants |
| PL3100 | Degree of GI Injury at Day 15 | Gastroduodenal Score of 2 or Less | 11 participants |
| Naproxen | Degree of GI Injury at Day 15 | Gastroduodenal Score of 3 or Higher | 20 participants |
| Naproxen | Degree of GI Injury at Day 15 | Gastroduodenal Score of 2 or Less | 13 participants |