Trial Outcomes & Findings for Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults (NCT NCT01139190)

Last Updated: 2016-04-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

77 participants

Primary outcome timeframe

15 days

Results posted on

2016-04-11

Participant Flow

Recruitment initiated: 01 July 2010, Multicenter trial: Private practice setting and Veterans Administration gastroenterology clinic.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	38	39
Overall Study COMPLETED	38	38
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PL3100 n=38 Participants 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.	Naproxen n=39 Participants 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.	Total n=77 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 5.97 • n=5 Participants	55.6 years STANDARD_DEVIATION 4.56 • n=7 Participants	56.1 years STANDARD_DEVIATION 5.29 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PL3100 n=34 Participants PL3100: Oral administration	Naproxen n=33 Participants Naproxen: Oral administration
Degree of GI Injury at Day 15 Gastroduodenal Score of 2 or Less	11 participants	13 participants
Degree of GI Injury at Day 15 Gastroduodenal Score of 3 or Higher	23 participants	20 participants

Adverse Events

PL3100

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Naproxen

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PL3100 n=38 participants at risk PL3100: Oral administration	Naproxen n=39 participants at risk Naproxen: Oral administration
Gastrointestinal disorders Abdominal Cramps	5.3% 2/38 • Number of events 2 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.	0.00% 0/39 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.
Gastrointestinal disorders Abdominal distension	5.3% 2/38 • Number of events 2 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.	0.00% 0/39 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.
Gastrointestinal disorders Constipation	5.3% 2/38 • Number of events 2 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.	0.00% 0/39 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.
Gastrointestinal disorders Duodenal ulcer	5.3% 2/38 • Number of events 2 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.	2.6% 1/39 • Number of events 1 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.
Gastrointestinal disorders Dyspepsia	15.8% 6/38 • Number of events 6 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.	2.6% 1/39 • Number of events 1 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.
Gastrointestinal disorders Nasusea	5.3% 2/38 • Number of events 2 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.	0.00% 0/39 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.
Gastrointestinal disorders Stomach ulcer	18.4% 7/38 • Number of events 7 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.	12.8% 5/39 • Number of events 5 Safety Population: all subjects who received at least 1 dose of study drug (naproxen or PL3100) under the study protocol.

Additional Information

Ronald Zimmerman, CEO & President

PLx Pharma LLC

Phone: 713-842-1249

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60