Trial Outcomes & Findings for Study of Postoperative Analgesia in Bunionectomy (NCT NCT00890682)
NCT ID: NCT00890682
Last Updated: 2013-08-05
Results Overview
The AUC of the NRS-R pain intensity scores from time 0 through 24 hours The subject was to rest 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?"
COMPLETED
PHASE3
193 participants
0-24 hours
2013-08-05
Participant Flow
Participant milestones
| Measure |
SKY0402
Injection of 8cc SKY0402 (single dose)
|
Placebo
Injection of 8cc Placebo (single dose)
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
96
|
|
Overall Study
COMPLETED
|
93
|
94
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Postoperative Analgesia in Bunionectomy
Baseline characteristics by cohort
| Measure |
Sky0402
n=97 Participants
Injection of Study Drug
|
Placebo
n=96 Participants
Study Drug Injection
|
Total
n=193 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
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
42.4 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
96 participants
n=7 Participants
|
193 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-24 hoursThe AUC of the NRS-R pain intensity scores from time 0 through 24 hours The subject was to rest 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
n=97 Participants
Single injection of study drug
|
Placebo
n=96 Participants
Single injection of study drug
|
|---|---|---|
|
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
|
124 Units on a scale*hours
Standard Error 4.5
|
146 Units on a scale*hours
Standard Error 4.6
|
SECONDARY outcome
Timeframe: 30 daysParticipants with an Adverse Event through 72 hours or a Serious Adverse Event through 30 days
Outcome measures
Outcome data not reported
Adverse Events
Sky0402
Placebo
Serious adverse events
| Measure |
Sky0402
n=97 participants at risk
Injection of Study Drug
|
Placebo
n=96 participants at risk
Study Drug Injection
|
|---|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/97
|
1.0%
1/96 • Number of events 1
|
Other adverse events
| Measure |
Sky0402
n=97 participants at risk
Injection of Study Drug
|
Placebo
n=96 participants at risk
Study Drug Injection
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
40.2%
39/97
|
37.5%
36/96
|
|
Gastrointestinal disorders
Vomiting
|
27.8%
27/97
|
17.7%
17/96
|
|
Nervous system disorders
Dizziness
|
11.3%
11/97
|
26.0%
25/96
|
|
Nervous system disorders
Headache
|
5.2%
5/97
|
8.3%
8/96
|
|
Nervous system disorders
Somnolence
|
5.2%
5/97
|
1.0%
1/96 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.2%
5/97
|
6.2%
6/96
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place