Trial Outcomes & Findings for Evaluation of Preoperative N1539 in Total Knee Arthroplasty (NCT NCT03434275)
NCT ID: NCT03434275
Last Updated: 2023-05-25
Results Overview
Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
194 participants
Primary outcome timeframe
Up to 24 Hours
Results posted on
2023-05-25
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
|
98
|
96
|
|
Overall Study
Treated
|
93
|
88
|
|
Overall Study
COMPLETED
|
93
|
88
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
N1539 30 mg
n=93 Participants
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
n=88 Participants
IV Placebo every 24 hours
Placebo: Once Daily
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 8.23 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 8.11 • n=7 Participants
|
66.2 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=7 Participants
|
2 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
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
144 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
|
93 participants
n=5 Participants
|
88 participants
n=7 Participants
|
181 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 24 HoursTotal use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.
Outcome measures
| Measure |
N1539 30 mg
n=93 Participants
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
n=88 Participants
IV Placebo every 24 hours
Placebo: Once Daily
|
|---|---|---|
|
Opioid Use Hour 0-24
|
18.94 mg morphine equivalent
Standard Error 1.320
|
27.73 mg morphine equivalent
Standard Error 1.371
|
Adverse Events
N1539 30 mg
Serious events: 3 serious events
Other events: 65 other events
Deaths: 0 deaths
IV Placebo
Serious events: 9 serious events
Other events: 81 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
N1539 30 mg
n=93 participants at risk
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
n=88 participants at risk
IV Placebo every 24 hours
Placebo: Once Daily
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/93 • Number of events 1 • Through 30 days post dose
|
0.00%
0/88 • Through 30 days post dose
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.1%
1/93 • Number of events 1 • Through 30 days post dose
|
0.00%
0/88 • Through 30 days post dose
|
|
Infections and infestations
Cellulitis
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
|
Nervous system disorders
Syncope
|
1.1%
1/93 • Number of events 1 • Through 30 days post dose
|
0.00%
0/88 • Through 30 days post dose
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/93 • Through 30 days post dose
|
2.3%
2/88 • Number of events 2 • Through 30 days post dose
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
|
Vascular disorders
Hypertension
|
0.00%
0/93 • Through 30 days post dose
|
1.1%
1/88 • Number of events 1 • Through 30 days post dose
|
Other adverse events
| Measure |
N1539 30 mg
n=93 participants at risk
N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily
|
IV Placebo
n=88 participants at risk
IV Placebo every 24 hours
Placebo: Once Daily
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
39.8%
37/93 • Number of events 42 • Through 30 days post dose
|
59.1%
52/88 • Number of events 55 • Through 30 days post dose
|
|
Gastrointestinal disorders
Vomiting
|
16.1%
15/93 • Number of events 16 • Through 30 days post dose
|
21.6%
19/88 • Number of events 19 • Through 30 days post dose
|
|
Cardiac disorders
Hypotension
|
14.0%
13/93 • Number of events 14 • Through 30 days post dose
|
14.8%
13/88 • Number of events 13 • Through 30 days post dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.1%
14/93 • Number of events 14 • Through 30 days post dose
|
11.4%
10/88 • Number of events 10 • Through 30 days post dose
|
|
Gastrointestinal disorders
Constipation
|
10.8%
10/93 • Number of events 10 • Through 30 days post dose
|
12.5%
11/88 • Number of events 11 • Through 30 days post dose
|
|
Nervous system disorders
Dizziness
|
6.5%
6/93 • Number of events 8 • Through 30 days post dose
|
5.7%
5/88 • Number of events 5 • Through 30 days post dose
|
|
Investigations
Pyrexia
|
7.5%
7/93 • Number of events 7 • Through 30 days post dose
|
5.7%
5/88 • Number of events 5 • Through 30 days post dose
|
|
Investigations
Hypokalemia
|
2.2%
2/93 • Number of events 2 • Through 30 days post dose
|
6.8%
6/88 • Number of events 6 • Through 30 days post dose
|
|
Vascular disorders
Hypertension
|
0.00%
0/93 • Through 30 days post dose
|
8.0%
7/88 • Number of events 7 • Through 30 days post dose
|
|
Nervous system disorders
Headache
|
1.1%
1/93 • Number of events 1 • Through 30 days post dose
|
5.7%
5/88 • Number of events 5 • Through 30 days post dose
|
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