Trial Outcomes & Findings for Study Assessing Pain Relief After Replacement of the Knee (NCT NCT05260008)
NCT ID: NCT05260008
Last Updated: 2025-08-14
Results Overview
NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
from 30 minutes post-surgery through hour 168 (Day 8)
Results posted on
2025-08-14
Participant Flow
Participant milestones
| Measure |
ATX-101 1000 mg
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
34
|
4
|
|
Overall Study
COMPLETED
|
37
|
36
|
34
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
ATX-101 1000 mg
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study Assessing Pain Relief After Replacement of the Knee
Baseline characteristics by cohort
| Measure |
ATX-101 1000 mg
n=37 Participants
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
n=37 Participants
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
n=34 Participants
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
n=4 Participants
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
46 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 8.12 • n=99 Participants
|
68.3 years
STANDARD_DEVIATION 6.89 • n=107 Participants
|
67.5 years
STANDARD_DEVIATION 7.62 • n=206 Participants
|
63.0 years
STANDARD_DEVIATION 12.38 • n=7 Participants
|
67.8 years
STANDARD_DEVIATION 7.69 • n=31 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
63 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
102 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
7 participants
n=206 Participants
|
0 participants
n=7 Participants
|
20 participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
13 participants
n=206 Participants
|
0 participants
n=7 Participants
|
33 participants
n=31 Participants
|
|
Region of Enrollment
Australia
|
20 participants
n=99 Participants
|
21 participants
n=107 Participants
|
14 participants
n=206 Participants
|
4 participants
n=7 Participants
|
59 participants
n=31 Participants
|
|
Body Mass Index (BMI)
|
30.39 kg/m2
STANDARD_DEVIATION 4.473 • n=99 Participants
|
31.20 kg/m2
STANDARD_DEVIATION 5.131 • n=107 Participants
|
33.01 kg/m2
STANDARD_DEVIATION 5.185 • n=206 Participants
|
29.58 kg/m2
STANDARD_DEVIATION 1.431 • n=7 Participants
|
31.42 kg/m2
STANDARD_DEVIATION 4.934 • n=31 Participants
|
PRIMARY outcome
Timeframe: from 30 minutes post-surgery through hour 168 (Day 8)Population: Full analysis set (FAS)
NRS-R for pain intensity is an 11-item scale from 0 to10 where participants rank the level of pain intensity. The NRS scale goes from No Pain (0) to Worst Imaginable Pain (10).
Outcome measures
| Measure |
ATX-101 1000 mg
n=37 Participants
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
n=37 Participants
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
n=34 Participants
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
n=4 Participants
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) for the Numeric Rating Scale at Rest (NRS-R) of Pain Intensity.
|
517.32 pain intensity score*hour
Standard Deviation 284.675
|
518.03 pain intensity score*hour
Standard Deviation 239.299
|
595.26 pain intensity score*hour
Standard Deviation 258.945
|
756.84 pain intensity score*hour
Standard Deviation 261.454
|
SECONDARY outcome
Timeframe: Surgical Closure to Day 30Population: Full Analysis Set (FAS)
Opioid free is defined as no opioid rescue medication was recorded for the timepoint displayed and onwards.
Outcome measures
| Measure |
ATX-101 1000 mg
n=37 Participants
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
n=37 Participants
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
n=34 Participants
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
n=4 Participants
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
|---|---|---|---|---|
|
Percentage of Subject Who Remain Opioid Free.
Surgical Closure - Day 30
|
3 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Percentage of Subject Who Remain Opioid Free.
Day 4 - Day 30
|
12 Participants
|
13 Participants
|
6 Participants
|
0 Participants
|
|
Percentage of Subject Who Remain Opioid Free.
Day 5 - Day 30
|
13 Participants
|
15 Participants
|
6 Participants
|
0 Participants
|
|
Percentage of Subject Who Remain Opioid Free.
Day 8 - Day 30
|
14 Participants
|
17 Participants
|
10 Participants
|
1 Participants
|
|
Percentage of Subject Who Remain Opioid Free.
Day 15 - Day 30
|
17 Participants
|
22 Participants
|
16 Participants
|
1 Participants
|
|
Percentage of Subject Who Remain Opioid Free.
Day 22 - Day 30
|
24 Participants
|
27 Participants
|
23 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Surgical Closure to Day 30, Opioid consumption is summarized descriptively every 24-hour period through Day 30Population: Full Analysis Set (FAS)
Total post-surgical use of rescue opioid medications (days).
Outcome measures
| Measure |
ATX-101 1000 mg
n=37 Participants
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
n=37 Participants
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
n=34 Participants
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
n=4 Participants
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
|---|---|---|---|---|
|
Total Post-surgical Use of Rescue Opioid Medications.
Surgical Closure - Hour 24 (Day 1)
|
63.153 IV Morphine Milligram Equivalent (MME)
Standard Deviation 62.6833
|
58.399 IV Morphine Milligram Equivalent (MME)
Standard Deviation 47.1712
|
43.283 IV Morphine Milligram Equivalent (MME)
Standard Deviation 29.0513
|
119.800 IV Morphine Milligram Equivalent (MME)
Standard Deviation 58.1316
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Hour 24 (Day 1) - Hour 48 (Day 2)
|
44.628 IV Morphine Milligram Equivalent (MME)
Standard Deviation 40.0835
|
33.566 IV Morphine Milligram Equivalent (MME)
Standard Deviation 29.9608
|
36.804 IV Morphine Milligram Equivalent (MME)
Standard Deviation 30.9289
|
107.250 IV Morphine Milligram Equivalent (MME)
Standard Deviation 50.5486
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Hour 48 (Day 2) - Hour 72 (Day 3)
|
30.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 25.1244
|
25.795 IV Morphine Milligram Equivalent (MME)
Standard Deviation 18.9251
|
32.550 IV Morphine Milligram Equivalent (MME)
Standard Deviation 21.3338
|
40.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 8.6603
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Hour 72 (Day 3) - Day 4
|
24.044 IV Morphine Milligram Equivalent (MME)
Standard Deviation 22.3062
|
23.783 IV Morphine Milligram Equivalent (MME)
Standard Deviation 19.7504
|
25.369 IV Morphine Milligram Equivalent (MME)
Standard Deviation 16.9465
|
35.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 22.9129
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 4 - Day 5
|
26.733 IV Morphine Milligram Equivalent (MME)
Standard Deviation 26.0054
|
22.214 IV Morphine Milligram Equivalent (MME)
Standard Deviation 18.1274
|
23.853 IV Morphine Milligram Equivalent (MME)
Standard Deviation 20.0357
|
37.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 19.8431
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 5 - Day 6
|
25.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 21.5058
|
24.063 IV Morphine Milligram Equivalent (MME)
Standard Deviation 22.5092
|
25.067 IV Morphine Milligram Equivalent (MME)
Standard Deviation 25.0933
|
40.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 22.9129
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 6 - Day 7
|
27.206 IV Morphine Milligram Equivalent (MME)
Standard Deviation 21.8818
|
18.923 IV Morphine Milligram Equivalent (MME)
Standard Deviation 13.2725
|
26.225 IV Morphine Milligram Equivalent (MME)
Standard Deviation 21.1209
|
27.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 15.6125
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 7 - Day 8
|
19.147 IV Morphine Milligram Equivalent (MME)
Standard Deviation 13.7509
|
16.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 9.7033
|
28.219 IV Morphine Milligram Equivalent (MME)
Standard Deviation 20.8734
|
18.750 IV Morphine Milligram Equivalent (MME)
Standard Deviation 9.9216
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 8 - Day 9
|
19.147 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.3089
|
21.042 IV Morphine Milligram Equivalent (MME)
Standard Deviation 17.0140
|
19.833 IV Morphine Milligram Equivalent (MME)
Standard Deviation 13.7369
|
25.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 17.3205
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 9 - Day 10
|
20.176 IV Morphine Milligram Equivalent (MME)
Standard Deviation 13.4768
|
15.045 IV Morphine Milligram Equivalent (MME)
Standard Deviation 8.3260
|
20.192 IV Morphine Milligram Equivalent (MME)
Standard Deviation 13.8241
|
20.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 11.4564
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 10 - Day 11
|
20.214 IV Morphine Milligram Equivalent (MME)
Standard Deviation 12.4216
|
17.591 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.9654
|
21.100 IV Morphine Milligram Equivalent (MME)
Standard Deviation 13.8824
|
12.750 IV Morphine Milligram Equivalent (MME)
Standard Deviation 3.1820
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 11 - Day 12
|
16.417 IV Morphine Milligram Equivalent (MME)
Standard Deviation 12.7201
|
14.208 IV Morphine Milligram Equivalent (MME)
Standard Deviation 11.3367
|
15.875 IV Morphine Milligram Equivalent (MME)
Standard Deviation 8.0770
|
15.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 7.5000
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 12 - Day 13
|
16.071 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.7289
|
15.900 IV Morphine Milligram Equivalent (MME)
Standard Deviation 9.1767
|
21.567 IV Morphine Milligram Equivalent (MME)
Standard Deviation 14.9354
|
12.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 4.3301
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 13 - Day 14
|
13.571 IV Morphine Milligram Equivalent (MME)
Standard Deviation 7.1195
|
14.591 IV Morphine Milligram Equivalent (MME)
Standard Deviation 7.5459
|
19.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 12.8504
|
30.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation NA
standard deviation cannot be calculated for one participant
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 14 - Day 15
|
20.200 IV Morphine Milligram Equivalent (MME)
Standard Deviation 17.2293
|
13.850 IV Morphine Milligram Equivalent (MME)
Standard Deviation 9.6149
|
14.091 IV Morphine Milligram Equivalent (MME)
Standard Deviation 6.5453
|
15.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.6066
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 15 - Day 16
|
17.045 IV Morphine Milligram Equivalent (MME)
Standard Deviation 11.6092
|
17.571 IV Morphine Milligram Equivalent (MME)
Standard Deviation 7.7051
|
12.321 IV Morphine Milligram Equivalent (MME)
Standard Deviation 8.5605
|
15.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.6066
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 16 - Day 17
|
14.821 IV Morphine Milligram Equivalent (MME)
Standard Deviation 7.8117
|
11.167 IV Morphine Milligram Equivalent (MME)
Standard Deviation 4.1307
|
18.682 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.6941
|
15.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.6066
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 17 - Day 18
|
14.271 IV Morphine Milligram Equivalent (MME)
Standard Deviation 8.7331
|
12.700 IV Morphine Milligram Equivalent (MME)
Standard Deviation 5.7359
|
10.232 IV Morphine Milligram Equivalent (MME)
Standard Deviation 8.8154
|
15.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.6066
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 18 - Day 19
|
17.981 IV Morphine Milligram Equivalent (MME)
Standard Deviation 20.5113
|
12.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 6.1237
|
11.411 IV Morphine Milligram Equivalent (MME)
Standard Deviation 9.1744
|
7.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 0.0000
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 19 - Day 20
|
17.550 IV Morphine Milligram Equivalent (MME)
Standard Deviation 14.2993
|
7.875 IV Morphine Milligram Equivalent (MME)
Standard Deviation 0.7500
|
14.722 IV Morphine Milligram Equivalent (MME)
Standard Deviation 10.1122
|
11.250 IV Morphine Milligram Equivalent (MME)
Standard Deviation 5.3033
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 20 - Day 21
|
17.778 IV Morphine Milligram Equivalent (MME)
Standard Deviation 15.1783
|
13.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 9.5481
|
12.563 IV Morphine Milligram Equivalent (MME)
Standard Deviation 5.2809
|
7.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 0.0000
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 21 - Day 22
|
17.273 IV Morphine Milligram Equivalent (MME)
Standard Deviation 14.3267
|
11.083 IV Morphine Milligram Equivalent (MME)
Standard Deviation 5.5083
|
10.972 IV Morphine Milligram Equivalent (MME)
Standard Deviation 4.9124
|
7.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 0.0000
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 22 - Day 23
|
19.861 IV Morphine Milligram Equivalent (MME)
Standard Deviation 17.0069
|
9.750 IV Morphine Milligram Equivalent (MME)
Standard Deviation 3.5707
|
13.750 IV Morphine Milligram Equivalent (MME)
Standard Deviation 5.6458
|
18.333 IV Morphine Milligram Equivalent (MME)
Standard Deviation 18.7639
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 23 - Day 24
|
16.750 IV Morphine Milligram Equivalent (MME)
Standard Deviation 14.1323
|
11.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 4.1683
|
11.250 IV Morphine Milligram Equivalent (MME)
Standard Deviation 4.1079
|
31.667 IV Morphine Milligram Equivalent (MME)
Standard Deviation 41.8579
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 24 - Day 25
|
13.906 IV Morphine Milligram Equivalent (MME)
Standard Deviation 14.7515
|
13.400 IV Morphine Milligram Equivalent (MME)
Standard Deviation 11.0872
|
13.750 IV Morphine Milligram Equivalent (MME)
Standard Deviation 3.0619
|
18.333 IV Morphine Milligram Equivalent (MME)
Standard Deviation 18.7639
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 25 - Day 26
|
18.750 IV Morphine Milligram Equivalent (MME)
Standard Deviation 14.2705
|
12.357 IV Morphine Milligram Equivalent (MME)
Standard Deviation 9.0725
|
13.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 3.3541
|
7.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 0.0000
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 26 - Day 27
|
9.844 IV Morphine Milligram Equivalent (MME)
Standard Deviation 6.1397
|
9.857 IV Morphine Milligram Equivalent (MME)
Standard Deviation 3.8699
|
11.250 IV Morphine Milligram Equivalent (MME)
Standard Deviation 7.5000
|
23.750 IV Morphine Milligram Equivalent (MME)
Standard Deviation 22.9810
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 27 - Day 28
|
18.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 20.6610
|
12.700 IV Morphine Milligram Equivalent (MME)
Standard Deviation 6.9964
|
10.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation 4.3301
|
—
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 28 - Day 29
|
17.917 IV Morphine Milligram Equivalent (MME)
Standard Deviation 19.1974
|
11.700 IV Morphine Milligram Equivalent (MME)
Standard Deviation 5.9224
|
6.563 IV Morphine Milligram Equivalent (MME)
Standard Deviation 1.8750
|
20.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation NA
standard deviation cannot be calculated for one participant
|
|
Total Post-surgical Use of Rescue Opioid Medications.
Day 29 - Day 30
|
47.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation NA
standard deviation cannot be calculated for one participant
|
16.000 IV Morphine Milligram Equivalent (MME)
Standard Deviation NA
standard deviation cannot be calculated for one participant
|
7.500 IV Morphine Milligram Equivalent (MME)
Standard Deviation 0.0000
|
—
|
SECONDARY outcome
Timeframe: Surgical Closure to Day 30Population: Full Analysis Set (FAS)
Time to first postsurgical use of rescue opioid medication (days).
Outcome measures
| Measure |
ATX-101 1000 mg
n=37 Participants
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
n=37 Participants
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
n=34 Participants
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
n=4 Participants
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
|---|---|---|---|---|
|
Time to First Rescue Opioid Medication.
|
0.478 Days
Standard Deviation 0.9862
|
0.257 Days
Standard Deviation 0.2571
|
0.491 Days
Standard Deviation 0.6925
|
0.223 Days
Standard Deviation 0.0820
|
Adverse Events
ATX-101 1000 mg
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
ATX-101 1500 mg
Serious events: 4 serious events
Other events: 25 other events
Deaths: 0 deaths
Bupivacaine Hydrochloride
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ATX-101 1000 mg
n=37 participants at risk
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
n=37 participants at risk
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
n=34 participants at risk
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
n=4 participants at risk
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Incision site discharge
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.9%
1/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.9%
1/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
Other adverse events
| Measure |
ATX-101 1000 mg
n=37 participants at risk
ATX-101 1000 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
ATX-101 1500 mg
n=37 participants at risk
ATX-101 1500 mg
ATX-101: ATX-101 (bupivacaine) implant, one-time administration into the surgical site
|
Bupivacaine Hydrochloride
n=34 participants at risk
bupivacaine hydrochloride
bupivacaine hydrochloride without epinephrine via local infiltration and/or nerve block
|
Saline Placebo
n=4 participants at risk
Saline Placebo
saline placebo (0.9%) sodium chloride via local infiltration
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
13.5%
5/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
10.8%
4/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
26.5%
9/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
25.0%
1/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
3/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
5.4%
2/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.9%
1/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Gastrointestinal disorders
Nausea
|
29.7%
11/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
27.0%
10/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
26.5%
9/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
50.0%
2/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.4%
2/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
10.8%
4/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
14.7%
5/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.1%
3/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
5.4%
2/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
11.8%
4/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Nervous system disorders
Dizziness
|
8.1%
3/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
16.2%
6/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
5.4%
2/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
11.8%
4/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
25.0%
1/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
4/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
5.9%
2/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
3/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
11.8%
4/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
General disorders
Implant site swelling
|
2.7%
1/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
8.1%
3/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
5.9%
2/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
0.00%
0/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.4%
2/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
5.4%
2/37 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
2.9%
1/34 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
25.0%
1/4 • Day 56
AEs were collected from the time of the investigational product administration and followed until the resolution of AE(s) or the Day 56 Visit, whichever occurred first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Material for public dissemination will be submitted to the Sponsor for review at least sixty (60) days (or the time specified in the Protocol if longer) prior to submission for publication, public dissemination, or review by a publication committee. Principal Investigator agrees that all reasonable comments made by the Sponsor in relation to a proposed publication by the Trial Site, any Other Trial Site, and/or the Principal Investigator will be incorporated into the publication.
- Publication restrictions are in place
Restriction type: OTHER