Trial Outcomes & Findings for Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers (NCT NCT00872534)
NCT ID: NCT00872534
Last Updated: 2015-08-11
Results Overview
Incidence of subjects with gastroduodenal composite scores of 3 or 4 (\> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
204 participants
Primary outcome timeframe
After 7 days of study medication
Results posted on
2015-08-11
Participant Flow
Participant milestones
| Measure |
PL-2200
PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days
|
Aspirin
Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
104
|
|
Overall Study
COMPLETED
|
97
|
101
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
PL-2200
n=100 Participants
PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days
|
Aspirin
n=104 Participants
Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 6.35 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 6.00 • n=7 Participants
|
57.3 years
STANDARD_DEVIATION 6.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 7 days of study medicationIncidence of subjects with gastroduodenal composite scores of 3 or 4 (\> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).
Outcome measures
| Measure |
PL-2200
n=91 Participants
PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days
|
Aspirin
n=90 Participants
Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days
|
|---|---|---|
|
Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
Gastroduodenal Composite Score of 3 or 4 (YES)
|
19 participants
|
36 participants
|
|
Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
Gastroduodenal Composite Score of 3 or 4 (NO)
|
72 participants
|
54 participants
|
Adverse Events
PL-2200
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Aspirin
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PL-2200
n=100 participants at risk
PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
acetylsalicylic acid: 325mg once a day for 7 days
|
Aspirin
n=104 participants at risk
Immediate release 325mg aspirin
acetylsalicylic acid: 325mg once a day for 7 days
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.0%
5/100 • Number of events 5
|
3.8%
4/104 • Number of events 4
|
|
Gastrointestinal disorders
Stomach Ulcer
|
3.0%
3/100 • Number of events 3
|
9.6%
10/104 • Number of events 10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Standard Confidentiality Agreement
- Publication restrictions are in place
Restriction type: OTHER