Trial Outcomes & Findings for Phase 2 Dose-Ranging Study of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy (NCT NCT00529126)
NCT ID: NCT00529126
Last Updated: 2021-03-04
Results Overview
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
0 to 72 hours
Results posted on
2021-03-04
Participant Flow
Participant milestones
| Measure |
SKY0402 High Dose (300mg)
SKY0402 300mg single dose administered intraoperatively via local infiltration.
|
SKY0402 Middle Dose (225mg)
A single dose 225mg SKY0402 administered intraoperatively via local infiltration.
|
SKY0402 Low Dose (75mg)
A single dose 75mg SKY0402 administered intraoperatively via local infiltration.
|
Bupivacaine HCl 75mg
A single dose of 75 mg bupivacaine administered intraoperatively via local infiltration
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
24
|
26
|
|
Overall Study
COMPLETED
|
25
|
25
|
24
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Dose-Ranging Study of SKY0402 for Prolonged Postoperative Analgesia in Subject Undergoing Hemorrhoidectomy
Baseline characteristics by cohort
| Measure |
SKY0402 High Dose
n=25 Participants
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
SKY0402 Middle Dose
n=25 Participants
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
SKY0402 Low Dose
n=24 Participants
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
Bupivacaine HCl
n=26 Participants
A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
44.2 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
43.4 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
9 participants
n=7 Participants
|
9 participants
n=5 Participants
|
14 participants
n=4 Participants
|
37 participants
n=21 Participants
|
|
Region of Enrollment
Georgia
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
12 participants
n=4 Participants
|
63 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0 to 72 hoursTo assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
Outcome measures
| Measure |
SKY0402 300mg
n=25 Participants
A single dose of SKY0402 300mg administered intraoperatively via local infiltration.
|
SKY0402 225mg
n=25 Participants
A single dose of SKY0402 225mg administered intraoperatively via local infiltration.
|
SKY0402 75mg
n=24 Participants
A single dose of SKY0402 75mg administered intraoperatively via local infiltration.
|
Bupivacaine HCl
n=26 Participants
A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) at Rest (NRS-R) Pain Intensity Scores From 0 Through 72 Hours
|
175 units on a scale*hrs
Standard Deviation 173
|
172 units on a scale*hrs
Standard Deviation 146
|
225 units on a scale*hrs
Standard Deviation 185
|
331 units on a scale*hrs
Standard Deviation 175
|
SECONDARY outcome
Timeframe: Up to 30 daysOutcome measures
Outcome data not reported
Adverse Events
SKY0402 High Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SKY0402 Middle Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SKY0402 Low Dose
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Bupivacaine HCl
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SKY0402 High Dose
n=25 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
SKY0402 Middle Dose
n=25 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
SKY0402 Low Dose
n=24 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
Bupivacaine HCl
n=26 participants at risk
A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
|
|---|---|---|---|---|
|
Vascular disorders
Rectal hemorrhage
|
0.00%
0/25
|
0.00%
0/25
|
4.2%
1/24 • Number of events 1
|
0.00%
0/26
|
Other adverse events
| Measure |
SKY0402 High Dose
n=25 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
SKY0402 Middle Dose
n=25 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
SKY0402 Low Dose
n=24 participants at risk
A single dose of study drug was to be administered intraoperatively via local infiltration.
|
Bupivacaine HCl
n=26 participants at risk
A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25
|
20.0%
5/25
|
12.5%
3/24
|
15.4%
4/26
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25
|
16.0%
4/25
|
12.5%
3/24
|
11.5%
3/26
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25
|
12.0%
3/25
|
4.2%
1/24
|
11.5%
3/26
|
Additional Information
Executive Medical Director
Pacira Pharmaceuticals, Inc.
Phone: 203-837-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place