Trial Outcomes & Findings for Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy (NCT NCT01710345)
NCT ID: NCT01710345
Last Updated: 2015-01-26
Results Overview
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
12 hours
Results posted on
2015-01-26
Participant Flow
Participant milestones
| Measure |
Sufentanil NanoTab 20 mcg
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
|
Sufentanil NanoTab 30 mcg
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
|
Placebo NanoTab
Placebo NanoTab as needed every 60 minutes for 12 hours
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
20
|
|
Overall Study
COMPLETED
|
37
|
35
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
1
|
Reasons for withdrawal
| Measure |
Sufentanil NanoTab 20 mcg
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
|
Sufentanil NanoTab 30 mcg
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
|
Placebo NanoTab
Placebo NanoTab as needed every 60 minutes for 12 hours
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
2
|
3
|
1
|
|
Overall Study
Drug Dosing Error
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
Baseline characteristics by cohort
| Measure |
Sufentanil NanoTab 20 mcg
n=40 Participants
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
|
Sufentanil NanoTab 30 mcg
n=40 Participants
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
|
Placebo NanoTab
n=20 Participants
Placebo NanoTab as needed every 60 minutes for 12 hours
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
20 participants
n=5 Participants
|
100 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 hoursThe primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
Outcome measures
| Measure |
Sufentanil NanoTab 20 mcg
n=40 Participants
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
|
Sufentanil NanoTab 30 mcg
n=40 Participants
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
|
Placebo NanoTab
n=20 Participants
Placebo NanoTab as needed every 60 minutes for 12 hours
|
|---|---|---|---|
|
SPID-12
|
-5.65 units on a scale
Standard Error 2.55
|
6.53 units on a scale
Standard Error 2.56
|
-7.12 units on a scale
Standard Error 3.64
|
Adverse Events
Sufentanil NanoTab 20 mcg
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Sufentanil NanoTab 30 mcg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo NanoTab
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sufentanil NanoTab 20 mcg
n=40 participants at risk
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
|
Sufentanil NanoTab 30 mcg
n=40 participants at risk
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
|
Placebo NanoTab
n=20 participants at risk
Placebo NanoTab as needed every 60 minutes for 12 hours
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteomyeolitis
|
2.5%
1/40 • Number of events 1 • 12 hours and then time discharge
|
0.00%
0/40 • 12 hours and then time discharge
|
0.00%
0/20 • 12 hours and then time discharge
|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 40 • 12 hours and then time discharge
|
0.00%
0/40 • 12 hours and then time discharge
|
0.00%
0/20 • 12 hours and then time discharge
|
Other adverse events
| Measure |
Sufentanil NanoTab 20 mcg
n=40 participants at risk
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
|
Sufentanil NanoTab 30 mcg
n=40 participants at risk
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
|
Placebo NanoTab
n=20 participants at risk
Placebo NanoTab as needed every 60 minutes for 12 hours
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
35.0%
14/40 • 12 hours and then time discharge
|
62.5%
25/40 • 12 hours and then time discharge
|
0.00%
0/20 • 12 hours and then time discharge
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
11/40 • 12 hours and then time discharge
|
32.5%
13/40 • 12 hours and then time discharge
|
0.00%
0/20 • 12 hours and then time discharge
|
|
General disorders
Feeling hot
|
7.5%
3/40 • 12 hours and then time discharge
|
2.5%
1/40 • 12 hours and then time discharge
|
0.00%
0/20 • 12 hours and then time discharge
|
|
Nervous system disorders
Dizziness
|
12.5%
5/40 • 12 hours and then time discharge
|
20.0%
8/40 • 12 hours and then time discharge
|
5.0%
1/20 • 12 hours and then time discharge
|
|
Nervous system disorders
Somnolence
|
5.0%
2/40 • 12 hours and then time discharge
|
22.5%
9/40 • 12 hours and then time discharge
|
0.00%
0/20 • 12 hours and then time discharge
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
12.5%
5/40 • 12 hours and then time discharge
|
10.0%
4/40 • 12 hours and then time discharge
|
0.00%
0/20 • 12 hours and then time discharge
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must be able to review and approve all published
- Publication restrictions are in place
Restriction type: OTHER