Trial Outcomes & Findings for A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain (NCT NCT01539538)
NCT ID: NCT01539538
Last Updated: 2015-10-01
Results Overview
Proportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
357 participants
Primary outcome timeframe
48 hours
Results posted on
2015-10-01
Participant Flow
Participant milestones
| Measure |
Sufentanil NanoTab PCA System/15 mcg
|
Morphine IV PCA
|
|---|---|---|
|
Overall Study
STARTED
|
177
|
180
|
|
Overall Study
COMPLETED
|
146
|
136
|
|
Overall Study
NOT COMPLETED
|
31
|
44
|
Reasons for withdrawal
| Measure |
Sufentanil NanoTab PCA System/15 mcg
|
Morphine IV PCA
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
18
|
|
Overall Study
Lack of Efficacy
|
13
|
16
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
PCA no longer required or PCA problem
|
3
|
7
|
Baseline Characteristics
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
Baseline characteristics by cohort
| Measure |
Sufentanil NanoTab PCA System/15 mcg
n=177 Participants
|
Morphine IV PCA
n=180 Participants
|
Total
n=357 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
|
85 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
92 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
64 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
64 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
177 participants
n=5 Participants
|
180 participants
n=7 Participants
|
357 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursProportion of patients responding good or excellent at 48-hour global assessment of method of pain control
Outcome measures
| Measure |
Sufentanil NanoTab PCA System/15 mcg
n=177 Participants
|
Morphine IV PCA
n=180 Participants
|
|---|---|---|
|
Patient Global Satisfaction
|
78.5 % patients reporting good or excellent
Interval 72.5 to 84.6
|
65.6 % patients reporting good or excellent
Interval 58.6 to 72.5
|
Adverse Events
Sufentanil NanoTab PCA System/15 mcg
Serious events: 6 serious events
Other events: 123 other events
Deaths: 0 deaths
Morphine IV PCA
Serious events: 7 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sufentanil NanoTab PCA System/15 mcg
n=177 participants at risk
|
Morphine IV PCA
n=180 participants at risk
|
|---|---|---|
|
Injury, poisoning and procedural complications
post-procedural bile leak
|
0.00%
0/177
|
0.56%
1/180
|
|
Blood and lymphatic system disorders
anaemia
|
0.56%
1/177
|
0.56%
1/180
|
|
Blood and lymphatic system disorders
methaemoglobinaemia
|
0.00%
0/177
|
0.56%
1/180
|
|
Cardiac disorders
atrial fibrillation
|
0.56%
1/177
|
0.56%
1/180
|
|
Injury, poisoning and procedural complications
anastomotic haemorrhage
|
0.00%
0/177
|
0.56%
1/180
|
|
Investigations
oxygen saturation decreased
|
0.00%
0/177
|
0.56%
1/180
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/177
|
0.56%
1/180
|
|
Respiratory, thoracic and mediastinal disorders
respiratory depression
|
0.56%
1/177
|
0.00%
0/180
|
|
Vascular disorders
haematoma
|
1.1%
2/177
|
0.00%
0/180
|
|
Injury, poisoning and procedural complications
post-operative ileus
|
0.56%
1/177
|
0.00%
0/180
|
|
Vascular disorders
hypotension
|
0.56%
1/177
|
0.00%
0/180
|
|
Nervous system disorders
syncope
|
0.56%
1/177
|
0.00%
0/180
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.56%
1/177
|
0.00%
0/180
|
|
Gastrointestinal disorders
ileus
|
0.00%
0/177
|
0.56%
1/180
|
|
Injury, poisoning and procedural complications
anastomotic leak
|
0.00%
0/177
|
0.56%
1/180
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
0.00%
0/177
|
0.56%
1/180
|
|
Infections and infestations
sepsis
|
0.00%
0/177
|
0.56%
1/180
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/177
|
0.56%
1/180
|
|
Vascular disorders
axillary vein thrombosis
|
0.56%
1/177
|
0.00%
0/180
|
|
Infections and infestations
clostridium difficile sepsis
|
0.56%
1/177
|
0.00%
0/180
|
|
Gastrointestinal disorders
peritonitis
|
0.00%
0/177
|
0.56%
1/180
|
Other adverse events
| Measure |
Sufentanil NanoTab PCA System/15 mcg
n=177 participants at risk
|
Morphine IV PCA
n=180 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
42.9%
76/177
|
40.0%
72/180
|
|
Gastrointestinal disorders
vomiting
|
13.0%
23/177
|
11.1%
20/180
|
|
Gastrointestinal disorders
constipation
|
11.3%
20/177
|
8.3%
15/180
|
|
Gastrointestinal disorders
dyspepsia
|
3.4%
6/177
|
1.1%
2/180
|
|
Investigations
oxygen saturation decreased
|
9.6%
17/177
|
9.4%
17/180
|
|
Nervous system disorders
headache
|
7.9%
14/177
|
6.7%
12/180
|
|
Nervous system disorders
dizziness
|
5.6%
10/177
|
3.3%
6/180
|
|
Psychiatric disorders
confusional state
|
2.3%
4/177
|
1.7%
3/180
|
|
Renal and urinary disorders
urinary retention
|
1.1%
2/177
|
2.8%
5/180
|
|
Skin and subcutaneous tissue disorders
pruritus
|
4.0%
7/177
|
7.8%
14/180
|
|
Vascular disorders
hypotension
|
6.2%
11/177
|
11.1%
20/180
|
|
Vascular disorders
orthostatic hypotension
|
2.3%
4/177
|
1.1%
2/180
|
|
Cardiac disorders
tachycardia
|
1.1%
2/177
|
1.7%
3/180
|
|
Cardiac disorders
bradycardia
|
0.56%
1/177
|
1.7%
3/180
|
|
Gastrointestinal disorders
dry mouth
|
1.7%
3/177
|
1.1%
2/180
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/177
|
1.7%
3/180
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/177
|
1.1%
2/180
|
|
General disorders
pyrexia
|
1.1%
2/177
|
1.7%
3/180
|
|
Injury, poisoning and procedural complications
procedural hypotension
|
0.00%
0/177
|
1.1%
2/180
|
|
Investigations
blood bilirubin increased
|
0.56%
1/177
|
1.1%
2/180
|
|
Metabolism and nutrition disorders
hyponatremia
|
0.00%
0/177
|
1.1%
2/180
|
|
Nervous system disorders
sedation
|
1.1%
2/177
|
0.56%
1/180
|
|
Nervous system disorders
somnolence
|
0.56%
1/177
|
1.1%
2/180
|
|
Psychiatric disorders
insomnia
|
0.56%
1/177
|
1.1%
2/180
|
|
Psychiatric disorders
agitation
|
1.1%
2/177
|
0.00%
0/180
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
1.1%
2/177
|
1.1%
2/180
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
1.1%
2/177
|
0.56%
1/180
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee prior review and approval required
- Publication restrictions are in place
Restriction type: OTHER