Trial Outcomes & Findings for Evaluation of Preoperative N1539 in Colorectal Surgery (NCT NCT03323385)
NCT ID: NCT03323385
Last Updated: 2023-06-18
Results Overview
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
57 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2023-06-18
Participant Flow
Participant milestones
| Measure |
N1539 30 mg
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
IV Placebo every 24 hours
Placebo: Once Daily
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
|
Overall Study
Dosed
|
27
|
28
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
N1539 30 mg
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
IV Placebo every 24 hours
Placebo: Once Daily
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Noncompliance
|
0
|
1
|
Baseline Characteristics
Evaluation of Preoperative N1539 in Colorectal Surgery
Baseline characteristics by cohort
| Measure |
N1539 30 mg
n=27 Participants
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
n=28 Participants
IV Placebo every 24 hours
Placebo: Once Daily
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: All randomized subjects
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery
Outcome measures
| Measure |
N1539 30 mg
n=27 Participants
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
n=28 Participants
IV Placebo every 24 hours
Placebo: Once Daily
|
|---|---|---|
|
Evaluation of Safety and Tolerability - Number of Subjects With an AE
|
23 participants
|
26 participants
|
Adverse Events
N1539 30 mg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
IV Placebo
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
N1539 30 mg
n=27 participants at risk
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
n=28 participants at risk
IV Placebo every 24 hours
Placebo: Once Daily
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
3.7%
1/27 • Number of events 1 • 30 days
|
7.1%
2/28 • Number of events 2 • 30 days
|
|
Infections and infestations
Incision site cellulitis
|
3.7%
1/27 • Number of events 1 • 30 days
|
0.00%
0/28 • 30 days
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
3.7%
1/27 • Number of events 1 • 30 days
|
0.00%
0/28 • 30 days
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/27 • 30 days
|
3.6%
1/28 • Number of events 1 • 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paranasal sinus benign neoplasm
|
0.00%
0/27 • 30 days
|
3.6%
1/28 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Urinary retention
|
3.7%
1/27 • Number of events 1 • 30 days
|
0.00%
0/28 • 30 days
|
Other adverse events
| Measure |
N1539 30 mg
n=27 participants at risk
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
n=28 participants at risk
IV Placebo every 24 hours
Placebo: Once Daily
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
9/27 • Number of events 11 • 30 days
|
50.0%
14/28 • Number of events 17 • 30 days
|
|
Gastrointestinal disorders
Vomiting
|
18.5%
5/27 • Number of events 5 • 30 days
|
17.9%
5/28 • Number of events 5 • 30 days
|
|
Gastrointestinal disorders
Ileus
|
3.7%
1/27 • Number of events 1 • 30 days
|
17.9%
5/28 • Number of events 5 • 30 days
|
|
Gastrointestinal disorders
Constipation
|
3.7%
1/27 • Number of events 1 • 30 days
|
7.1%
2/28 • Number of events 2 • 30 days
|
|
Renal and urinary disorders
Urinary retention
|
7.4%
2/27 • Number of events 2 • 30 days
|
0.00%
0/28 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER