Trial Outcomes & Findings for A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery (NCT NCT00718081)
NCT ID: NCT00718081
Last Updated: 2015-01-22
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 scores after summing could range from -122 to +122. A higher SPID-12 score is better.
COMPLETED
PHASE2
88 participants
12 hours after surgery
2015-01-22
Participant Flow
Participant milestones
| Measure |
Sufentanil NanoTab 10 mcg
|
Sufentanil NanoTab 15 mcg
|
Placebo NanoTab
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
30
|
|
Overall Study
COMPLETED
|
22
|
25
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
21
|
Reasons for withdrawal
| Measure |
Sufentanil NanoTab 10 mcg
|
Sufentanil NanoTab 15 mcg
|
Placebo NanoTab
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
7
|
3
|
21
|
Baseline Characteristics
A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Major Abdominal Surgery
Baseline characteristics by cohort
| Measure |
Sufentanil NanoTab 10 mcg
n=29 Participants
|
Sufentanil NanoTab 15 mcg
n=29 Participants
|
Placebo NanoTab
n=30 Participants
|
Total
n=88 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
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
46.8 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
46.2 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
30 participants
n=5 Participants
|
88 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 hours after surgeryThe 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 scores after summing could range from -122 to +122. A higher SPID-12 score is better.
Outcome measures
| Measure |
Sufentanil NanoTab 10 mcg
n=29 Participants
|
Sufentanil NanoTab 15 mcg
n=29 Participants
|
Placebo NanoTab
n=30 Participants
|
|---|---|---|---|
|
SPID-12
|
22.41 units on a scale
Standard Error 3.61
|
27.56 units on a scale
Standard Error 3.50
|
2.93 units on a scale
Standard Error 3.46
|
SECONDARY outcome
Timeframe: Up to 12 hours after surgeryAt the end of the 12-hour study period each patient rated their overall pain relief since starting study drug on a 5-point scale: poor, fair, good, very good or excellent.
Outcome measures
| Measure |
Sufentanil NanoTab 10 mcg
n=29 Participants
|
Sufentanil NanoTab 15 mcg
n=29 Participants
|
Placebo NanoTab
n=30 Participants
|
|---|---|---|---|
|
Proportion of Patients Who Responded Very Good or Excellent in Patient Global Evaluation of Pain Relief
|
38 percentage of patients
|
55 percentage of patients
|
10 percentage of patients
|
Adverse Events
Sufentanil NanoTab 10 mcg
Sufentanil NanoTab 15 mcg
Placebo NanoTab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sufentanil NanoTab 10 mcg
n=29 participants at risk
|
Sufentanil NanoTab 15 mcg
n=29 participants at risk
|
Placebo NanoTab
n=30 participants at risk
|
|---|---|---|---|
|
Nervous system disorders
dizziness
|
3.4%
1/29
|
0.00%
0/29
|
3.3%
1/30
|
|
Nervous system disorders
headache
|
6.9%
2/29
|
3.4%
1/29
|
6.7%
2/30
|
|
Psychiatric disorders
insomnia
|
3.4%
1/29
|
3.4%
1/29
|
0.00%
0/30
|
|
Gastrointestinal disorders
nausea
|
44.8%
13/29
|
48.3%
14/29
|
40.0%
12/30
|
|
Skin and subcutaneous tissue disorders
pruritus
|
6.9%
2/29
|
17.2%
5/29
|
3.3%
1/30
|
|
General disorders
pyrexia
|
0.00%
0/29
|
0.00%
0/29
|
3.3%
1/30
|
|
Gastrointestinal disorders
vomiting
|
6.9%
2/29
|
0.00%
0/29
|
6.7%
2/30
|
|
Gastrointestinal disorders
abdominal distension
|
3.4%
1/29
|
0.00%
0/29
|
6.7%
2/30
|
|
General disorders
hypothermia
|
0.00%
0/29
|
0.00%
0/29
|
3.3%
1/30
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
0.00%
0/29
|
3.4%
1/29
|
0.00%
0/30
|
|
Vascular disorders
hypotension
|
0.00%
0/29
|
0.00%
0/29
|
3.3%
1/30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee requires prior consent
- Publication restrictions are in place
Restriction type: OTHER