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 Elective Unilateral Total Knee Replacement (NCT NCT00612534)
NCT ID: NCT00612534
Last Updated: 2014-02-17
Results Overview
SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.
COMPLETED
PHASE2
94 participants
12 hours after first dose
2014-02-17
Participant Flow
Participant milestones
| Measure |
Sufentanil NanoTab 5 Mcg
|
Sufentanil NanoTab 10 Mcg
|
Sufentanil NanoTab 15 Mcg
|
Placebo NanoTab
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
20
|
24
|
|
Overall Study
COMPLETED
|
11
|
9
|
13
|
7
|
|
Overall Study
NOT COMPLETED
|
13
|
17
|
7
|
17
|
Reasons for withdrawal
| Measure |
Sufentanil NanoTab 5 Mcg
|
Sufentanil NanoTab 10 Mcg
|
Sufentanil NanoTab 15 Mcg
|
Placebo NanoTab
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
13
|
12
|
5
|
16
|
|
Overall Study
Other Reason
|
0
|
1
|
0
|
0
|
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 Elective Unilateral Total Knee Replacement
Baseline characteristics by cohort
| Measure |
Sufentanil NanoTab 5 Mcg
n=24 Participants
|
Sufentanil NanoTab 10 Mcg
n=26 Participants
|
Sufentanil NanoTab 15 Mcg
n=20 Participants
|
Placebo NanoTab
n=24 Participants
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
62.8 years
STANDARD_DEVIATION 8.7 • n=21 Participants
|
|
Age, Customized
<40 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, Customized
40 to 64 years
|
15 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
11 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
9 participants
n=5 Participants
|
14 participants
n=7 Participants
|
10 participants
n=5 Participants
|
13 participants
n=4 Participants
|
46 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
20 participants
n=5 Participants
|
24 participants
n=4 Participants
|
94 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 hours after first dosePopulation: One patient in Sufentanil NanoTab 10 mcg group received the incorrect treatment so was not included in efficacy analysis
SPID-12 is the sum of the pain intensity difference (PID) over the 12 hour time period. A pain intensity score of 0 (no pain) to 10 (worst possible pain) is obtained before starting the study and throughout the 12 hour time period. The pain score at each assessment time point is subtracted from the baseline pain score (starting point) to provide the total sum score or SPID-12. A higher SPID-12 score is better and indicates a reduction in pain intensity compared to the baseline score. Per protocol, pain scores are collected at 15 different time points. If all scores are collected, the full range of SPID-12 scores could be -150 to 150.
Outcome measures
| Measure |
Sufentanil NanoTab 5 Mcg
n=24 Participants
|
Sufentanil NanoTab 10 Mcg
n=25 Participants
|
Sufentanil NanoTab 15 Mcg
n=20 Participants
|
Placebo NanoTab
n=24 Participants
|
|---|---|---|---|---|
|
SPID-12
|
2.87 units on a scale
Standard Error 5.68
|
1.28 units on a scale
Standard Error 5.60
|
12.66 units on a scale
Standard Error 6.25
|
-7.39 units on a scale
Standard Error 5.71
|
Adverse Events
Sufentanil NanoTab 5 Mcg
Sufentanil NanoTab 10 Mcg
Sufentanil NanoTab 15 Mcg
Placebo NanoTab
Serious adverse events
| Measure |
Sufentanil NanoTab 5 Mcg
n=24 participants at risk
|
Sufentanil NanoTab 10 Mcg
n=26 participants at risk
|
Sufentanil NanoTab 15 Mcg
n=20 participants at risk
|
Placebo NanoTab
n=24 participants at risk
|
|---|---|---|---|---|
|
Renal and urinary disorders
acute renal failure
|
0.00%
0/24
|
0.00%
0/26
|
5.0%
1/20 • Number of events 2
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
chest pain
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/20
|
4.2%
1/24 • Number of events 1
|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
hypercapnia
|
0.00%
0/24
|
3.8%
1/26 • Number of events 1
|
0.00%
0/20
|
0.00%
0/24
|
Other adverse events
| Measure |
Sufentanil NanoTab 5 Mcg
n=24 participants at risk
|
Sufentanil NanoTab 10 Mcg
n=26 participants at risk
|
Sufentanil NanoTab 15 Mcg
n=20 participants at risk
|
Placebo NanoTab
n=24 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
nausea
|
29.2%
7/24
|
34.6%
9/26
|
20.0%
4/20
|
20.8%
5/24
|
|
Gastrointestinal disorders
vomiting
|
8.3%
2/24
|
15.4%
4/26
|
15.0%
3/20
|
4.2%
1/24
|
|
Nervous system disorders
somnolence
|
4.2%
1/24
|
0.00%
0/26
|
10.0%
2/20
|
4.2%
1/24
|
|
Respiratory, thoracic and mediastinal disorders
respiratory depression
|
0.00%
0/24
|
7.7%
2/26
|
0.00%
0/20
|
4.2%
1/24
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/24
|
0.00%
0/26
|
5.0%
1/20
|
4.2%
1/24
|
|
Investigations
neutrophil count increased
|
4.2%
1/24
|
0.00%
0/26
|
0.00%
0/20
|
4.2%
1/24
|
|
Nervous system disorders
dizziness
|
12.5%
3/24
|
3.8%
1/26
|
5.0%
1/20
|
0.00%
0/24
|
|
Investigations
white blood cell count increased
|
4.2%
1/24
|
0.00%
0/26
|
0.00%
0/20
|
4.2%
1/24
|
|
Vascular disorders
hypotension
|
0.00%
0/24
|
3.8%
1/26
|
0.00%
0/20
|
4.2%
1/24
|
|
Cardiac disorders
bradycardia
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/20
|
4.2%
1/24
|
|
Cardiac disorders
tachycardia
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/20
|
4.2%
1/24
|
|
General disorders
fatigue
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/20
|
4.2%
1/24
|
|
General disorders
pyrexia
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/20
|
4.2%
1/24
|
|
Investigations
lymphocyte count increased
|
0.00%
0/24
|
0.00%
0/26
|
0.00%
0/20
|
4.2%
1/24
|
|
Skin and subcutaneous tissue disorders
pruritus
|
4.2%
1/24
|
7.7%
2/26
|
5.0%
1/20
|
0.00%
0/24
|
|
Investigations
oxygen saturation decreased
|
0.00%
0/24
|
3.8%
1/26
|
5.0%
1/20
|
0.00%
0/24
|
|
Nervous system disorders
headache
|
0.00%
0/24
|
0.00%
0/26
|
10.0%
2/20
|
0.00%
0/24
|
|
Gastrointestinal disorders
oral mucosal discoloration
|
0.00%
0/24
|
0.00%
0/26
|
5.0%
1/20
|
0.00%
0/24
|
|
Investigations
alanine aminotransferase increased
|
4.2%
1/24
|
0.00%
0/26
|
0.00%
0/20
|
0.00%
0/24
|
|
Investigations
aspartate aminotransferase increased
|
4.2%
1/24
|
0.00%
0/26
|
0.00%
0/20
|
0.00%
0/24
|
|
Investigations
blood lactate dehydrogenase increased
|
4.2%
1/24
|
0.00%
0/26
|
0.00%
0/20
|
0.00%
0/24
|
|
Nervous system disorders
lethargy
|
0.00%
0/24
|
3.8%
1/26
|
0.00%
0/20
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
hypoventilation
|
0.00%
0/24
|
3.8%
1/26
|
0.00%
0/20
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
nasal discomfort
|
0.00%
0/24
|
3.8%
1/26
|
0.00%
0/20
|
0.00%
0/24
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee prior written consent of sponsor
- Publication restrictions are in place
Restriction type: OTHER