Trial Outcomes & Findings for A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery (NCT NCT01539642)
NCT ID: NCT01539642
Last Updated: 2015-10-20
Results Overview
SPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
172 participants
Primary outcome timeframe
48 hours
Results posted on
2015-10-20
Participant Flow
Recruitment period of 10 months - March 1, 2012 to December 28, 2012; Recruitment and screening occurred at clinical research centers and hospitals.
Patients were excluded per protocol exclusion criteria at Screening as well as post surgery for certain issues including the following: 1. Patients who were not awake or stable 2. Patients with arterial oxygen saturation that couldn't be maintained at 95% or greater 3. Patients with uncontrollable vomiting
Participant milestones
| Measure |
Sufentanil NanoTab PCA System/15 mcg
Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
|
Placebo Sufentanil NanoTab PCA System
Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
58
|
|
Overall Study
COMPLETED
|
78
|
27
|
|
Overall Study
NOT COMPLETED
|
36
|
31
|
Reasons for withdrawal
| Measure |
Sufentanil NanoTab PCA System/15 mcg
Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
|
Placebo Sufentanil NanoTab PCA System
Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
20
|
18
|
|
Overall Study
Patient ready for early discharge
|
8
|
7
|
|
Overall Study
Adverse Event
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery
Baseline characteristics by cohort
| Measure |
Sufentanil NanoTab PCA System/15 mcg
n=114 Participants
Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
|
Placebo Sufentanil NanoTab PCA System
n=58 Participants
Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
|
Total
n=172 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
|
91 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Continuous
|
54.2 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
57.4 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
55.2 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
58 participants
n=7 Participants
|
172 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hoursSPID-48 is the sum of the pain intensity difference (PID) over the 48 hour time period. A pain intensity score of 0 (no pain) to 10 (worse possible pain) is obtained before starting the study and throughout the 48 time period. The pain score at each assessment time is subtracted from the baseline pain score to provide the total sum score or SPID-48. A higher SPID-48 is better and indicates a reduction in pain intensity compared to the baseline score. The range of SPID48 scores were -232 to 326. Time-weighted SPID48 = ∑ \[T(i) - T(i-1)\] x PID(i), where T(0) = Time 0 (baseline), T(i) is the scheduled or unscheduled assessment time, and PID(i) is the PID score at time i for i=0 to 48 hours. Note: Active group n=114 and placebo group n=58, instead of active n=115 and placebo n=57, due to one "active" patient receiving placebo inadvertently.
Outcome measures
| Measure |
Sufentanil NanoTab PCA System/15 mcg
n=114 Participants
Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
|
Placebo Sufentanil NanoTab PCA System
n=58 Participants
Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
|
|---|---|---|
|
Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48).
|
105.60 Units on a scale
Standard Error 10.14
|
55.58 Units on a scale
Standard Error 13.11
|
Adverse Events
Sufentanil NanoTab PCA System/15 mcg
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo Sufentanil NanoTab PCA System
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sufentanil NanoTab PCA System/15 mcg
n=114 participants at risk
Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
|
Placebo Sufentanil NanoTab PCA System
n=58 participants at risk
Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.88%
1/114 • Number of events 1 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
0.00%
0/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
Other adverse events
| Measure |
Sufentanil NanoTab PCA System/15 mcg
n=114 participants at risk
Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
|
Placebo Sufentanil NanoTab PCA System
n=58 participants at risk
Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
2.6%
3/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
1.7%
1/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.88%
1/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
1.7%
1/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
14.0%
16/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
22.4%
13/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
Investigations
Oxygen Saturation Decreased
|
3.5%
4/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
1.7%
1/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
5/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
0.00%
0/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
1.8%
2/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
0.00%
0/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
4/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
3.4%
2/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
1.7%
1/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
1.7%
1/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
1.8%
2/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
0.00%
0/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
|
General disorders
Chest Pain
|
0.00%
0/114 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
1.7%
1/58 • Treatment period of 48 hours (patients could elect to stay in study up to 72 hours). AEs collected from time of first dose of study drug through 12 hours after last dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60