Trial Outcomes & Findings for Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects (NCT NCT01646814)

NCT ID: NCT01646814

Last Updated: 2022-06-07

Results Overview

Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 247 participants
• Primary outcome timeframe: 42 Days
• Results posted on: 2022-06-07

Participant Flow

Participant milestones

Measure	PL2200 Investigational product, PL2200 PL2200: PL2200, containing 325 mg aspirin active ingredient	Aspirin Tablets Active comparator, 325 mg aspirin tablets Aspirin tablets: 325 mg aspirin tablets (USP)
Overall Study STARTED	121	126
Overall Study COMPLETED	110	120
Overall Study NOT COMPLETED	11	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

Baseline characteristics by cohort

Measure	PL2200 n=121 Participants Investigational product, PL2200 PL2200: PL2200, containing 325 mg aspirin active ingredient	Aspirin Tablets n=126 Participants Active comparator, 325 mg aspirin tablets Aspirin tablets: 325 mg aspirin tablets (USP)	Total n=247 Participants Total of all reporting groups
Age, Customized ≥ 50 and ≤ 75 years	121 participants n=5 Participants	126 participants n=7 Participants	247 participants n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	82 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	44 Participants n=7 Participants	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: 42 Days

Population: Per protocol population (ie, Treated with ≥1 dose and Day 7 dose administered and endoscopy performed and ≥85% compliant)

Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth

Outcome measures

Measure	PL2200 n=113 Participants Investigational product, PL2200 PL2200: PL2200, containing 325 mg aspirin active ingredient	Aspirin Tablets n=119 Participants Active comparator, 325 mg aspirin tablets Aspirin tablets: 325 mg aspirin tablets (USP)
Incidence of Gastroduodenal Ulcers	28 participants	34 participants

SECONDARY outcome

Timeframe: 42 days

Population: Full analysis set population, as randomized. Subjects treated with at least one dose of study drug and day 7 endoscopy

>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy

Outcome measures

Measure	PL2200 n=119 Participants Investigational product, PL2200 PL2200: PL2200, containing 325 mg aspirin active ingredient	Aspirin Tablets n=121 Participants Active comparator, 325 mg aspirin tablets Aspirin tablets: 325 mg aspirin tablets (USP)
Number of Subjects With Erosion and Ulcers	56 Participants	76 Participants

Adverse Events

PL2200

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Aspirin Tablets

Serious events: 0 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PL2200 n=121 participants at risk Investigational product, PL2200 PL2200: PL2200, containing 325 mg aspirin active ingredient	Aspirin Tablets n=126 participants at risk Active comparator, 325 mg aspirin tablets Aspirin tablets: 325 mg aspirin tablets (USP)
Gastrointestinal disorders Dyspepsia	8.3% 10/121 • Number of events 10 Safety Population: participants treated with ≥ 1 dose	7.1% 9/126 • Number of events 9 Safety Population: participants treated with ≥ 1 dose
Gastrointestinal disorders Gastric Ulcer	21.5% 26/121 • Number of events 26 Safety Population: participants treated with ≥ 1 dose	24.6% 31/126 • Number of events 31 Safety Population: participants treated with ≥ 1 dose
Gastrointestinal disorders Oesophagitis	7.4% 9/121 • Number of events 9 Safety Population: participants treated with ≥ 1 dose	10.3% 13/126 • Number of events 13 Safety Population: participants treated with ≥ 1 dose
Nervous system disorders Headache	12.4% 15/121 • Number of events 15 Safety Population: participants treated with ≥ 1 dose	11.9% 15/126 • Number of events 15 Safety Population: participants treated with ≥ 1 dose

Additional Information

Regulatory Affairs Director

PLxPharma

Phone: 17138421249

Email: regaffairs@plxpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60