Trial Outcomes & Findings for Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain (NCT NCT02915978)
NCT ID: NCT02915978
Last Updated: 2018-02-14
Results Overview
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum(max)=10 at each time point\], and negative numbers indicate an increase in pain \[minimum(min)=-10 at each time point\]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Over 0 to 48 hours after Time 0
Results posted on
2018-02-14
Participant Flow
Participant milestones
| Measure |
Higher Dose Fentanyl Sublingual Spray
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Higher Dose Fentanyl Sublingual Spray
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
Baseline Characteristics
Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain
Baseline characteristics by cohort
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
46.4 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
39 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 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
|
PRIMARY outcome
Timeframe: Over 0 to 48 hours after Time 0Population: All randomized participants from the Intent-to-Treat (ITT) population.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum(max)=10 at each time point\], and negative numbers indicate an increase in pain \[minimum(min)=-10 at each time point\]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0
|
151.7 units on a scale
Standard Deviation 95.52
|
126.4 units on a scale
Standard Deviation 124.66
|
149.0 units on a scale
Standard Deviation 115.26
|
SECONDARY outcome
Timeframe: Baseline, 1, 16, and 24 hoursPopulation: All randomized participants from the Intent-to-Treat (ITT) population.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled time point relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline. NRS PID is reported as the least squares mean difference.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0
Baseline
|
6.5 units on a scale
Standard Deviation 1.64
|
6.1 units on a scale
Standard Deviation 2.13
|
7.1 units on a scale
Standard Deviation 2.22
|
|
NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0
1 Hour
|
3.7 units on a scale
Standard Deviation 2.46
|
4.3 units on a scale
Standard Deviation 2.09
|
5.8 units on a scale
Standard Deviation 2.96
|
|
NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0
16 Hours
|
2.6 units on a scale
Standard Deviation 2.18
|
3.9 units on a scale
Standard Deviation 3.04
|
5.5 units on a scale
Standard Deviation 2.23
|
|
NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0
24 Hours
|
2.0 units on a scale
Standard Deviation 1.96
|
3.2 units on a scale
Standard Deviation 2.21
|
3.3 units on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Baseline, 1, 16, and 24 hoursPopulation: All randomized participants from the Intent-to-Treat (ITT) population.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
NRS Pain Intensity Score at Each Scheduled Time Point After Time 0
16 Hours
|
2.6 units on a scale
Standard Deviation 2.18
|
3.9 units on a scale
Standard Deviation 3.04
|
5.5 units on a scale
Standard Deviation 2.23
|
|
NRS Pain Intensity Score at Each Scheduled Time Point After Time 0
Baseline
|
6.5 units on a scale
Standard Deviation 1.64
|
6.1 units on a scale
Standard Deviation 2.13
|
7.1 units on a scale
Standard Deviation 2.22
|
|
NRS Pain Intensity Score at Each Scheduled Time Point After Time 0
1 Hour
|
3.7 units on a scale
Standard Deviation 2.46
|
4.3 units on a scale
Standard Deviation 2.09
|
5.8 units on a scale
Standard Deviation 2.96
|
|
NRS Pain Intensity Score at Each Scheduled Time Point After Time 0
24 hours
|
2.0 units on a scale
Standard Deviation 1.96
|
3.2 units on a scale
Standard Deviation 2.21
|
3.3 units on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Over 0 to 4 hours (NRS SPID-4), over 0 to 8 hours (NRS SPID-8), and over 0 to 24 hours (NRS SPID-24)Population: All randomized participants from the Intent-to-Treat (ITT) population.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum(max)=10 at each timepoint\], and negative numbers indicate an increase in pain \[minimum(min)=-10 at each timepoint\]. The overall min and max are -10 and 10 times the number of hours specified: SPID-4=(-40 to 40), SPID-8=(-80 to 80) and SPID-24=(-240 to 240). The NRS SPID-4, 8 and 24 were analyzed using an ANCOVA model which included treatment and site as main effects and Baseline pain intensity as the covariate.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
NRS SPID After Time 0
Over 24 Hours
|
67.4 units on a scale
Standard Deviation 40.45
|
51.7 units on a scale
Standard Deviation 53.43
|
51.7 units on a scale
Standard Deviation 59.38
|
|
NRS SPID After Time 0
Over 8 Hours
|
13.6 units on a scale
Standard Deviation 14.59
|
11.2 units on a scale
Standard Deviation 16.18
|
8.8 units on a scale
Standard Deviation 19.70
|
|
NRS SPID After Time 0
Over 4 Hours
|
6.6 units on a scale
Standard Deviation 7.58
|
5.9 units on a scale
Standard Deviation 8.79
|
4.8 units on a scale
Standard Deviation 12.73
|
SECONDARY outcome
Timeframe: Over 0 to 4 hours (TOTPAR-4), over 0 to 8 hours (TOTPAR-8), over 0 to 24 hours (TOTPAR-24), and over 0 to 48 hours (TOTPAR-48)Population: All randomized participants from the Intent-to-Treat (ITT) population.
TOTPAR was assessed by the participant using a 5-point NRS (0=no relief, 1=a little, 2=some, 3=a lot, 4=complete relief). TOTPAR scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (first dose of study drug). The TOTPAR scores are the sum of the pain relief at each time point multiplied by the duration in hours since the previous time point. Larger positive numbers indicate more pain relief (maximum=4 at each time point) and smaller positive numbers indicate less pain relief (minimum=0 at each time point). The overall minimum is 0 for each variable and the overall maximum is 4 times the number of hours specified for the variable: TOTPAR-4=(0 to 16), TOTPAR-8=(0 to 32), TOTPAR-24=(0 to 96) and TOTPAR-48=(0 to 192). TOTPAR-4, TOTPAR-8, TOTPAR-24 and TOTPAR-48 were analyzed using an ANCOVA model with factors for treatment, site and baseline pain intensity.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Total Pain Relief (TOTPAR) After Time 0
Over 48 Hours
|
98.2 units on a scale
Standard Deviation 55.25
|
99.9 units on a scale
Standard Deviation 33.63
|
98.2 units on a scale
Standard Deviation 33.32
|
|
Total Pain Relief (TOTPAR) After Time 0
Over 24 Hours
|
43.8 units on a scale
Standard Deviation 22.72
|
46.5 units on a scale
Standard Deviation 16.87
|
38.3 units on a scale
Standard Deviation 14.81
|
|
Total Pain Relief (TOTPAR) After Time 0
Over 8 Hours
|
11.6 units on a scale
Standard Deviation 8.53
|
10.6 units on a scale
Standard Deviation 6.32
|
7.2 units on a scale
Standard Deviation 5.33
|
|
Total Pain Relief (TOTPAR) After Time 0
Over 4 Hours
|
5.3 units on a scale
Standard Deviation 4.54
|
5.1 units on a scale
Standard Deviation 3.77
|
3.9 units on a scale
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: Within 48 hoursPopulation: All randomized participants from the Intent-to-Treat (ITT) population.
Measured as time to perceptible pain relief confirmed by meaningful pain relief using the 2-stopwatch method (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Time to Onset of Analgesia
|
5 minutes
Interval 2.0 to 16.0
|
184 minutes
Interval 1.0 to
Not estimable because less than 50% of participants achieved onset.
|
NA minutes
Interval 4.0 to
Not estimable because less than 50% of participants achieved onset.
|
SECONDARY outcome
Timeframe: 2.5, 5, 15, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours, as well as immediately before each use of rescue analgesiaPopulation: All randomized participants from the Intent-to-Treat (ITT) population. The number analyzed differs in the later time points for the Fentanyl groups because some participants withdrew over the course of the study.
Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
15 Minutes After Time 0 · Some Relief
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
32 Hours After Time 0 · Some Relief
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2.5 Minutes After Time 0 · No Relief
|
9 Participants
|
9 Participants
|
11 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2.5 Minutes After Time 0 · A Little Relief
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2.5 Minutes After Time 0 · Some Relief
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2.5 Minutes After Time 0 · A Lot of Relief
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2.5 Minutes After Time 0 · Complete Relief
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Minutes After Time 0 · No Relief
|
6 Participants
|
9 Participants
|
10 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Minutes After Time 0 · A Little Relief
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Minutes After Time 0 · Some Relief
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Minutes After Time 0 · A Lot of Relief
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Minutes After Time 0 · Complete Relief
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
15 Minutes After Time 0 · No Relief
|
5 Participants
|
3 Participants
|
9 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
15 Minutes After Time 0 · A Little Relief
|
3 Participants
|
9 Participants
|
3 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
15 Minutes After Time 0 · A Lot of Relief
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
15 Minutes After Time 0 · Complete Relief
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
30 Minutes After Time 0 - No Relief · No Relief
|
3 Participants
|
3 Participants
|
9 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
30 Minutes After Time 0 - No Relief · A Little Relief
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
30 Minutes After Time 0 - No Relief · Some Relief
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
30 Minutes After Time 0 - No Relief · A Lot of Relief
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
30 Minutes After Time 0 - No Relief · Complete Relief
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
45 Minutes After Time 0 · No Relief
|
3 Participants
|
4 Participants
|
7 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
45 Minutes After Time 0 · A Little Relief
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
45 Minutes After Time 0 · Some Relief
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
45 Minutes After Time 0 · A Lot of Relief
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
45 Minutes After Time 0 · Complete Relief
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1 Hour After Time 0 · No Relief
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1 Hour After Time 0 · A Little Relief
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1 Hour After Time 0 · Some Relief
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1 Hour After Time 0 · A Lot of Relief
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1 Hour After Time 0 · Complete Relief
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1.5 Hours After Time 0 · No Relief
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1.5 Hours After Time 0 · A Little Relief
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1.5 Hours After Time 0 · Some Relief
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1.5 Hours After Time 0 · A Lot of Relief
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
1.5 Hours After Time 0 · Complete Relief
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2 Hours After Time 0 · No Relief
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2 Hours After Time 0 · A Little Relief
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2 Hours After Time 0 · Some Relief
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2 Hours After Time 0 · A Lot of Relief
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
2 Hours After Time 0 · Complete Relief
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
3 Hours After Time 0 · No Relief
|
7 Participants
|
5 Participants
|
7 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
3 Hours After Time 0 · A Little Relief
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
3 Hours After Time 0 · Some Relief
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
3 Hours After Time 0 · A Lot of Relief
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
3 Hours After Time 0 · Complete Relief
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
4 Hours After Time 0 · No Relief
|
7 Participants
|
6 Participants
|
9 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
4 Hours After Time 0 · A Little Relief
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
4 Hours After Time 0 · Some Relief
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
4 Hours After Time 0 · A Lot of Relief
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
4 Hours After Time 0 · Complete Relief
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Hours After Time 0 · No Relief
|
8 Participants
|
8 Participants
|
9 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Hours After Time 0 · A Little Relief
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Hours After Time 0 · Some Relief
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Hours After Time 0 · A Lot of Relief
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
5 Hours After Time 0 · Complete Relief
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
6 Hours After Time 0 · No Relief
|
6 Participants
|
6 Participants
|
8 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
6 Hours After Time 0 · A Little Relief
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
6 Hours After Time 0 · Some Relief
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
6 Hours After Time 0 · A Lot of Relief
|
4 Participants
|
3 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
6 Hours After Time 0 · Complete Relief
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
7 Hours After Time 0 · No Relief
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
7 Hours After Time 0 · A Little Relief
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
7 Hours After Time 0 · Some Relief
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
7 Hours After Time 0 · A Lot of Relief
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
7 Hours After Time 0 · Complete Relief
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
8 Hours After Time 0 · No Relief
|
5 Participants
|
5 Participants
|
8 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
8 Hours After Time 0 · A Little Relief
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
8 Hours After Time 0 · Some Relief
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
8 Hours After Time 0 · A Lot of Relief
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
8 Hours After Time 0 · Complete Relief
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
12 Hours After Time 0 · No Relief
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
12 Hours After Time 0 · A Little Relief
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
12 Hours After Time 0 · Some Relief
|
2 Participants
|
7 Participants
|
5 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
12 Hours After Time 0 · A Lot of Relief
|
6 Participants
|
4 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
12 Hours After Time 0 · Complete Relief
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
16 Hours After Time 0 · No Relief
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
16 Hours After Time 0 · A Little Relief
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
16 Hours After Time 0 · Some Relief
|
2 Participants
|
3 Participants
|
6 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
16 Hours After Time 0 · A Lot of Relief
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
16 Hours After Time 0 · Complete Relief
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
20 Hours After Time 0 · No Relief
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
20 Hours After Time 0 · A Little Relief
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
20 Hours After Time 0 · Some Relief
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
20 Hours After Time 0 · A Lot of Relief
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
20 Hours After Time 0 · Complete Relief
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
24 Hours After Time 0 · No Relief
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
24 Hours After Time 0 · A Little Relief
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
24 Hours After Time 0 · Some Relief
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
24 Hours After Time 0 · A Lot of Relief
|
6 Participants
|
9 Participants
|
6 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
24 Hours After Time 0 · Complete Relief
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
32 Hours After Time 0 · No Relief
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
32 Hours After Time 0 · A Little Relief
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
32 Hours After Time 0 · A Lot of Relief
|
3 Participants
|
8 Participants
|
8 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
32 Hours After Time 0 · Complete Relief
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
40 Hours After Time 0 · No Relief
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
40 Hours After Time 0 · A Little Relief
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
40 Hours After Time 0 · Some Relief
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
40 Hours After Time 0 · A Lot of Relief
|
3 Participants
|
5 Participants
|
7 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
40 Hours After Time 0 · Complete Relief
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
48 Hours After Time 0 · No Relief
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
48 Hours After Time 0 · A Little Relief
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
48 Hours After Time 0 · Some Relief
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
48 Hours After Time 0 · A Lot of Relief
|
4 Participants
|
6 Participants
|
6 Participants
|
|
Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
48 Hours After Time 0 · Complete Relief
|
5 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours after Time 0Population: All randomized participants from the Intent-to-Treat (ITT) population.
The highest level of pain relief achieved on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Peak Pain Relief From Time 0 (First Dose of Study Medication)
A Lot of Relief
|
5 Participants
|
11 Participants
|
7 Participants
|
|
Peak Pain Relief From Time 0 (First Dose of Study Medication)
A Little Relief
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Peak Pain Relief From Time 0 (First Dose of Study Medication)
Some Relief
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Peak Pain Relief From Time 0 (First Dose of Study Medication)
Complete Relief
|
8 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours after Time 0Population: All randomized participants from the Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication)
|
300.0 minutes
Interval 30.0 to 955.0
|
420.0 minutes
Interval 90.0 to 1198.0
|
1198 minutes
Interval 45.0 to 1912.0
|
SECONDARY outcome
Timeframe: Within 48 hours after Time 0Population: All randomized participants from the Intent-to-Treat (ITT) population.
Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication)
|
5 minutes
Interval 2.0 to 15.0
|
10 minutes
Interval 1.0 to 15.0
|
20 minutes
Interval 3.0 to
Not estimable because less than 50% of participants achieved perceptible pain relief.
|
SECONDARY outcome
Timeframe: Within 48 hours after Time 0Population: All randomized participants from the Intent-to-Treat (ITT) population.
Time to perceptible and meaningful pain relief will be evaluated using the 2-stopwatch method (after the first dose only) (2 stopwatches will be started as soon as the first dose of study drug is administered. Each participant will be instructed to stop the first stopwatch when he or she experiences any perceptible pain relief and the second stopwatch when he or she experiences pain relief that is meaningful to them.)
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication)
|
49 minutes
Interval 10.0 to 87.0
|
190 minutes
Interval 21.0 to
Not estimable because less than 50% of participants achieved meaningful pain relief.
|
79 minutes
Interval 14.0 to
Not estimable because less than 50% of participants achieved meaningful pain relief.
|
SECONDARY outcome
Timeframe: Within 48 hoursPopulation: All randomized participants from the Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Number of Participants Using Rescue Medication
Rescue Medication Used
|
11 Participants
|
12 Participants
|
15 Participants
|
|
Number of Participants Using Rescue Medication
No Rescue Medication Used
|
4 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 48 hoursPopulation: All randomized participants from the Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP)
|
204.0 minutes
Interval 85.0 to 370.0
|
289.0 minutes
Interval 98.0 to 431.0
|
126.0 minutes
Interval 50.0 to 225.0
|
SECONDARY outcome
Timeframe: Over 0 to 24 hours; Over 0 to 48 hoursPopulation: All randomized participants from the Intent-to-Treat (ITT) population.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours
Over 24 Hours
|
11 Participants
|
12 Participants
|
15 Participants
|
|
Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours
Over 48 hours
|
11 Participants
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Within 48 hoursPopulation: All randomized participants from the Intent-to-Treat (ITT) population.
Participants provide a global evaluation of study drug on a 5-point categorical scale where 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent.
Outcome measures
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 Participants
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 Participants
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 Participants
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Participant Global Evaluation of Study Drug
Poor
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Participant Global Evaluation of Study Drug
Fair
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Participant Global Evaluation of Study Drug
Good
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Participant Global Evaluation of Study Drug
Very Good
|
3 Participants
|
3 Participants
|
8 Participants
|
|
Participant Global Evaluation of Study Drug
Excellent
|
6 Participants
|
4 Participants
|
2 Participants
|
Adverse Events
Higher Dose Fentanyl Sublingual Spray
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Lower Dose Fentanyl Sublingual Spray
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Higher Dose Fentanyl Sublingual Spray
n=15 participants at risk
Higher dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Lower Dose Fentanyl Sublingual Spray
n=15 participants at risk
Lower dose Fentanyl delivered via sublingual spray every 4 hours.
Fentanyl: Fentanyl delivered via sublingual spray
|
Placebo
n=15 participants at risk
Placebo (matching Fentany) delivered via sublingual spray every 4 hours.
Placebo: Matching placebo delivered via sublingual spray
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
66.7%
10/15 • Baseline up to 37 days approximately.
|
26.7%
4/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
|
Gastrointestinal disorders
Vomiting
|
53.3%
8/15 • Baseline up to 37 days approximately.
|
13.3%
2/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
General disorders
Application Site Pain
|
20.0%
3/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
|
General disorders
Asthenia
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
General disorders
Burning Sensation
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
13.3%
2/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
13.3%
2/15 • Baseline up to 37 days approximately.
|
|
Musculoskeletal and connective tissue disorders
Restless Leg Syndrome
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • Baseline up to 37 days approximately.
|
13.3%
2/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
|
Nervous system disorders
Headache
|
26.7%
4/15 • Baseline up to 37 days approximately.
|
20.0%
3/15 • Baseline up to 37 days approximately.
|
20.0%
3/15 • Baseline up to 37 days approximately.
|
|
Nervous system disorders
Hypoaesthesia
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
3/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Swelling
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
|
Vascular disorders
Hot Flush
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
|
Vascular disorders
Hypotension
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
6.7%
1/15 • Baseline up to 37 days approximately.
|
0.00%
0/15 • Baseline up to 37 days approximately.
|
Additional Information
Director, Clinical Development
Insys Therapeutics, Inc.
Phone: 480-500-3105
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place