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Trial record 10 of 56 for:    insys

Fentanyl Sublingual Spray for the Treatment of Moderate to Severe Post-Operative Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02915978
Recruitment Status : Completed
First Posted : September 27, 2016
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Fentanyl
Drug: Placebo
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Placebo
Hide Arm/Group Description

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Period Title: Overall Study
Started 15 15 15
Completed 13 14 15
Not Completed 2 1 0
Reason Not Completed
Adverse Event             2             1             0
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo Total
Hide Arm/Group Description

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 45 participants
43.8  (14.3) 50.0  (10.6) 45.5  (11.4) 46.4  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
Female
12
  80.0%
12
  80.0%
14
  93.3%
38
  84.4%
Male
3
  20.0%
3
  20.0%
1
   6.7%
7
  15.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
Hispanic or Latino
2
  13.3%
1
   6.7%
3
  20.0%
6
  13.3%
Not Hispanic or Latino
13
  86.7%
14
  93.3%
12
  80.0%
39
  86.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
2
  13.3%
2
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  26.7%
6
  40.0%
4
  26.7%
14
  31.1%
White
11
  73.3%
9
  60.0%
9
  60.0%
29
  64.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours (NRS SPID-48) After Time 0
Hide Description 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.
Time Frame Over 0 to 48 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
151.7  (95.52) 126.4  (124.66) 149.0  (115.26)
2.Secondary Outcome
Title NRS Pain Intensity Difference (NRS PID) at Each Categorical Time Point After Time 0
Hide Description 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.
Time Frame Baseline, 1, 16, and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.5  (1.64) 6.1  (2.13) 7.1  (2.22)
1 Hour 3.7  (2.46) 4.3  (2.09) 5.8  (2.96)
16 Hours 2.6  (2.18) 3.9  (3.04) 5.5  (2.23)
24 Hours 2.0  (1.96) 3.2  (2.21) 3.3  (2.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Higher Dose Fentanyl Sublingual Spray, Placebo
Comments NRS PID at 1 hour
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0505
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-3.61 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.89
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lower Dose Fentanyl Sublingual Spray, Placebo
Comments NRS PID at 1 hour
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2493
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.06
Confidence Interval (2-Sided) 95%
-2.89 to 0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Higher Dose Fentanyl Sublingual Spray, Placebo
Comments NRS PID at 16 hours
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0052
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.94
Confidence Interval (2-Sided) 95%
-4.95 to -0.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Lower Dose Fentanyl Sublingual Spray, Placebo
Comments NRS PID at 16 hours
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0926
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.67
Confidence Interval (2-Sided) 95%
-3.62 to 0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.97
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Higher Dose Fentanyl Sublingual Spray, Placebo
Comments NRS PID at 24 hours
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0951
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value -1.40
Confidence Interval (2-Sided) 95%
-3.06 to 0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.82
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Lower Dose Fentanyl Sublingual Spray, Placebo
Comments NRS PID at 24 hours
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9866
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-1.60 to 1.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.80
Estimation Comments [Not Specified]
3.Secondary Outcome
Title NRS Pain Intensity Score at Each Scheduled Time Point After Time 0
Hide Description 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.
Time Frame Baseline, 1, 16, and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 6.5  (1.64) 6.1  (2.13) 7.1  (2.22)
1 Hour 3.7  (2.46) 4.3  (2.09) 5.8  (2.96)
16 Hours 2.6  (2.18) 3.9  (3.04) 5.5  (2.23)
24 hours 2.0  (1.96) 3.2  (2.21) 3.3  (2.64)
4.Secondary Outcome
Title NRS SPID After Time 0
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Over 24 Hours 67.4  (40.45) 51.7  (53.43) 51.7  (59.38)
Over 8 Hours 13.6  (14.59) 11.2  (16.18) 8.8  (19.70)
Over 4 Hours 6.6  (7.58) 5.9  (8.79) 4.8  (12.73)
5.Secondary Outcome
Title Total Pain Relief (TOTPAR) After Time 0
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
Over 48 Hours 98.2  (55.25) 99.9  (33.63) 98.2  (33.32)
Over 24 Hours 43.8  (22.72) 46.5  (16.87) 38.3  (14.81)
Over 8 Hours 11.6  (8.53) 10.6  (6.32) 7.2  (5.33)
Over 4 Hours 5.3  (4.54) 5.1  (3.77) 3.9  (4.53)
6.Secondary Outcome
Title Time to Onset of Analgesia
Hide Description 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.)
Time Frame Within 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (95% Confidence Interval)
Unit of Measure: minutes
5
(2 to 16)
184 [1] 
(1 to NA)
NA [1] 
(4 to NA)
[1]
Not estimable because less than 50% of participants achieved onset.
7.Secondary Outcome
Title Pain Relief at Each Scheduled Time Point After Time 0 (First Dose of Study Medication)
Hide Description Pain relief is determined on a 5-point categorical scale where 0=none, 1=a little, 2=some, 3=a lot, 4=complete.
Time Frame 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 analgesia
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
2.5 Minutes After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
9
  60.0%
9
  60.0%
11
  73.3%
A Little Relief
4
  26.7%
3
  20.0%
2
  13.3%
Some Relief
1
   6.7%
3
  20.0%
1
   6.7%
A Lot of Relief
1
   6.7%
0
   0.0%
1
   6.7%
Complete Relief
0
   0.0%
0
   0.0%
0
   0.0%
5 Minutes After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
6
  40.0%
9
  60.0%
10
  66.7%
A Little Relief
6
  40.0%
3
  20.0%
2
  13.3%
Some Relief
2
  13.3%
2
  13.3%
2
  13.3%
A Lot of Relief
1
   6.7%
1
   6.7%
1
   6.7%
Complete Relief
0
   0.0%
0
   0.0%
0
   0.0%
15 Minutes After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
5
  33.3%
3
  20.0%
9
  60.0%
A Little Relief
3
  20.0%
9
  60.0%
3
  20.0%
Some Relief
2
  13.3%
2
  13.3%
1
   6.7%
A Lot of Relief
5
  33.3%
1
   6.7%
1
   6.7%
Complete Relief
0
   0.0%
0
   0.0%
1
   6.7%
30 Minutes After Time 0 - No Relief Number Analyzed 15 participants 15 participants 15 participants
No Relief
3
  20.0%
3
  20.0%
9
  60.0%
A Little Relief
4
  26.7%
6
  40.0%
2
  13.3%
Some Relief
1
   6.7%
4
  26.7%
1
   6.7%
A Lot of Relief
5
  33.3%
2
  13.3%
2
  13.3%
Complete Relief
2
  13.3%
0
   0.0%
1
   6.7%
45 Minutes After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
3
  20.0%
4
  26.7%
7
  46.7%
A Little Relief
6
  40.0%
4
  26.7%
5
  33.3%
Some Relief
1
   6.7%
4
  26.7%
0
   0.0%
A Lot of Relief
2
  13.3%
3
  20.0%
1
   6.7%
Complete Relief
3
  20.0%
0
   0.0%
2
  13.3%
1 Hour After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
3
  20.0%
5
  33.3%
6
  40.0%
A Little Relief
5
  33.3%
3
  20.0%
5
  33.3%
Some Relief
3
  20.0%
4
  26.7%
2
  13.3%
A Lot of Relief
2
  13.3%
3
  20.0%
0
   0.0%
Complete Relief
2
  13.3%
0
   0.0%
2
  13.3%
1.5 Hours After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
5
  33.3%
4
  26.7%
6
  40.0%
A Little Relief
4
  26.7%
3
  20.0%
2
  13.3%
Some Relief
2
  13.3%
4
  26.7%
5
  33.3%
A Lot of Relief
3
  20.0%
4
  26.7%
0
   0.0%
Complete Relief
1
   6.7%
0
   0.0%
2
  13.3%
2 Hours After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
7
  46.7%
6
  40.0%
7
  46.7%
A Little Relief
3
  20.0%
3
  20.0%
4
  26.7%
Some Relief
0
   0.0%
3
  20.0%
2
  13.3%
A Lot of Relief
4
  26.7%
3
  20.0%
0
   0.0%
Complete Relief
1
   6.7%
0
   0.0%
2
  13.3%
3 Hours After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
7
  46.7%
5
  33.3%
7
  46.7%
A Little Relief
3
  20.0%
4
  26.7%
3
  20.0%
Some Relief
1
   6.7%
4
  26.7%
2
  13.3%
A Lot of Relief
2
  13.3%
2
  13.3%
2
  13.3%
Complete Relief
2
  13.3%
0
   0.0%
1
   6.7%
4 Hours After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
7
  46.7%
6
  40.0%
9
  60.0%
A Little Relief
4
  26.7%
3
  20.0%
4
  26.7%
Some Relief
0
   0.0%
2
  13.3%
1
   6.7%
A Lot of Relief
3
  20.0%
4
  26.7%
1
   6.7%
Complete Relief
1
   6.7%
0
   0.0%
0
   0.0%
5 Hours After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
8
  53.3%
8
  53.3%
9
  60.0%
A Little Relief
2
  13.3%
3
  20.0%
5
  33.3%
Some Relief
1
   6.7%
0
   0.0%
1
   6.7%
A Lot of Relief
1
   6.7%
4
  26.7%
0
   0.0%
Complete Relief
3
  20.0%
0
   0.0%
0
   0.0%
6 Hours After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
6
  40.0%
6
  40.0%
8
  53.3%
A Little Relief
3
  20.0%
2
  13.3%
3
  20.0%
Some Relief
0
   0.0%
3
  20.0%
3
  20.0%
A Lot of Relief
4
  26.7%
3
  20.0%
1
   6.7%
Complete Relief
2
  13.3%
1
   6.7%
0
   0.0%
7 Hours After Time 0 Number Analyzed 15 participants 15 participants 15 participants
No Relief
6
  40.0%
5
  33.3%
8
  53.3%
A Little Relief
2
  13.3%
1
   6.7%
2
  13.3%
Some Relief
0
   0.0%
4
  26.7%
2
  13.3%
A Lot of Relief
4
  26.7%
5
  33.3%
3
  20.0%
Complete Relief
3
  20.0%
0
   0.0%
0
   0.0%
8 Hours After Time 0 Number Analyzed 14 participants 15 participants 15 participants
No Relief
5
  35.7%
5
  33.3%
8
  53.3%
A Little Relief
0
   0.0%
2
  13.3%
2
  13.3%
Some Relief
3
  21.4%
4
  26.7%
1
   6.7%
A Lot of Relief
4
  28.6%
3
  20.0%
4
  26.7%
Complete Relief
2
  14.3%
1
   6.7%
0
   0.0%
12 Hours After Time 0 Number Analyzed 13 participants 15 participants 15 participants
No Relief
3
  23.1%
2
  13.3%
2
  13.3%
A Little Relief
1
   7.7%
2
  13.3%
4
  26.7%
Some Relief
2
  15.4%
7
  46.7%
5
  33.3%
A Lot of Relief
6
  46.2%
4
  26.7%
4
  26.7%
Complete Relief
1
   7.7%
0
   0.0%
0
   0.0%
16 Hours After Time 0 Number Analyzed 13 participants 15 participants 15 participants
No Relief
1
   7.7%
1
   6.7%
4
  26.7%
A Little Relief
3
  23.1%
4
  26.7%
4
  26.7%
Some Relief
2
  15.4%
3
  20.0%
6
  40.0%
A Lot of Relief
5
  38.5%
6
  40.0%
1
   6.7%
Complete Relief
2
  15.4%
1
   6.7%
0
   0.0%
20 Hours After Time 0 Number Analyzed 13 participants 15 participants 15 participants
No Relief
1
   7.7%
1
   6.7%
1
   6.7%
A Little Relief
4
  30.8%
2
  13.3%
2
  13.3%
Some Relief
1
   7.7%
4
  26.7%
4
  26.7%
A Lot of Relief
3
  23.1%
6
  40.0%
6
  40.0%
Complete Relief
4
  30.8%
2
  13.3%
2
  13.3%
24 Hours After Time 0 Number Analyzed 13 participants 15 participants 15 participants
No Relief
0
   0.0%
0
   0.0%
1
   6.7%
A Little Relief
3
  23.1%
2
  13.3%
2
  13.3%
Some Relief
2
  15.4%
3
  20.0%
4
  26.7%
A Lot of Relief
6
  46.2%
9
  60.0%
6
  40.0%
Complete Relief
2
  15.4%
1
   6.7%
2
  13.3%
32 Hours After Time 0 Number Analyzed 13 participants 14 participants 15 participants
No Relief
1
   7.7%
0
   0.0%
2
  13.3%
A Little Relief
3
  23.1%
2
  14.3%
3
  20.0%
Some Relief
2
  15.4%
3
  21.4%
0
   0.0%
A Lot of Relief
3
  23.1%
8
  57.1%
8
  53.3%
Complete Relief
4
  30.8%
1
   7.1%
2
  13.3%
40 Hours After Time 0 Number Analyzed 13 participants 14 participants 15 participants
No Relief
2
  15.4%
0
   0.0%
1
   6.7%
A Little Relief
1
   7.7%
3
  21.4%
2
  13.3%
Some Relief
2
  15.4%
5
  35.7%
4
  26.7%
A Lot of Relief
3
  23.1%
5
  35.7%
7
  46.7%
Complete Relief
5
  38.5%
1
   7.1%
1
   6.7%
48 Hours After Time 0 Number Analyzed 13 participants 14 participants 15 participants
No Relief
1
   7.7%
0
   0.0%
1
   6.7%
A Little Relief
2
  15.4%
4
  28.6%
0
   0.0%
Some Relief
1
   7.7%
3
  21.4%
4
  26.7%
A Lot of Relief
4
  30.8%
6
  42.9%
6
  40.0%
Complete Relief
5
  38.5%
1
   7.1%
4
  26.7%
8.Secondary Outcome
Title Peak Pain Relief From Time 0 (First Dose of Study Medication)
Hide Description 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.
Time Frame Within 48 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
A Little Relief
2
  13.3%
0
   0.0%
0
   0.0%
Some Relief
0
   0.0%
1
   6.7%
2
  13.3%
A Lot of Relief
5
  33.3%
11
  73.3%
7
  46.7%
Complete Relief
8
  53.3%
3
  20.0%
6
  40.0%
9.Secondary Outcome
Title Time (Minutes) to Peak Pain Relief From Time 0 (First Dose of Study Medication)
Hide Description [Not Specified]
Time Frame Within 48 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (95% Confidence Interval)
Unit of Measure: minutes
300.0
(30 to 955)
420.0
(90 to 1198)
1198
(45 to 1912)
10.Secondary Outcome
Title Time (Minutes) to First Perceptible Pain Relief From Time 0 (First Dose of Study Medication)
Hide Description 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.)
Time Frame Within 48 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (95% Confidence Interval)
Unit of Measure: minutes
5
(2 to 15)
10
(1 to 15)
20 [1] 
(3 to NA)
[1]
Not estimable because less than 50% of participants achieved perceptible pain relief.
11.Secondary Outcome
Title Time (Minutes) to Meaningful Pain Relief From Time 0 (First Dose of Study Medication)
Hide Description 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.)
Time Frame Within 48 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (95% Confidence Interval)
Unit of Measure: minutes
49
(10 to 87)
190 [1] 
(21 to NA)
79 [1] 
(14 to NA)
[1]
Not estimable because less than 50% of participants achieved meaningful pain relief.
12.Secondary Outcome
Title Number of Participants Using Rescue Medication
Hide Description [Not Specified]
Time Frame Within 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Rescue Medication Used
11
  73.3%
12
  80.0%
15
 100.0%
No Rescue Medication Used
4
  26.7%
3
  20.0%
0
   0.0%
13.Secondary Outcome
Title Time (Minutes) to First Use of Rescue Medication (Duration of Analgesia) Following Each Dose of the Investigational Product (IP)
Hide Description [Not Specified]
Time Frame Within 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Mean (95% Confidence Interval)
Unit of Measure: minutes
204.0
(85 to 370)
289.0
(98 to 431)
126.0
(50 to 225)
14.Secondary Outcome
Title Number of Participants Using Rescue Analgesia Over 0 to 24 Hours and Over 0 to 48 Hours
Hide Description [Not Specified]
Time Frame Over 0 to 24 hours; Over 0 to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Over 24 Hours
11
  73.3%
12
  80.0%
15
 100.0%
Over 48 hours
11
  73.3%
12
  80.0%
15
 100.0%
15.Secondary Outcome
Title Participant Global Evaluation of Study Drug
Hide Description 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.
Time Frame Within 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the Intent-to-Treat (ITT) population.
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description:

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

Overall Number of Participants Analyzed 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Poor
2
  13.3%
3
  20.0%
4
  26.7%
Fair
3
  20.0%
2
  13.3%
0
   0.0%
Good
1
   6.7%
3
  20.0%
1
   6.7%
Very Good
3
  20.0%
3
  20.0%
8
  53.3%
Excellent
6
  40.0%
4
  26.7%
2
  13.3%
Time Frame Baseline up to 37 days approximately.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Hide Arm/Group Description

Higher dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Lower dose Fentanyl delivered via sublingual spray every 4 hours.

Fentanyl: Fentanyl delivered via sublingual spray

Placebo (matching Fentany) delivered via sublingual spray every 4 hours.

Placebo: Matching placebo delivered via sublingual spray

All-Cause Mortality
Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Higher Dose Fentanyl Sublingual Spray Lower Dose Fentanyl Sublingual Spray Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/15 (80.00%)   8/15 (53.33%)   6/15 (40.00%) 
Gastrointestinal disorders       
Nausea  1  10/15 (66.67%)  4/15 (26.67%)  1/15 (6.67%) 
Vomiting  1  8/15 (53.33%)  2/15 (13.33%)  0/15 (0.00%) 
General disorders       
Application Site Pain  1  3/15 (20.00%)  0/15 (0.00%)  1/15 (6.67%) 
Asthenia  1  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Burning Sensation  1  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Infections and infestations       
Upper Respiratory Tract Infection  1  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Vulvovaginal Mycotic Infection  1  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Back Pain  1  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
Muscle Spasms  1  1/15 (6.67%)  0/15 (0.00%)  1/15 (6.67%) 
Myalgia  1  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Pain in Extremity  1  2/15 (13.33%)  0/15 (0.00%)  2/15 (13.33%) 
Restless Leg Syndrome  1  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Nervous system disorders       
Dizziness  1  4/15 (26.67%)  2/15 (13.33%)  1/15 (6.67%) 
Headache  1  4/15 (26.67%)  3/15 (20.00%)  3/15 (20.00%) 
Hypoaesthesia  1  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Hypoxia  1  3/15 (20.00%)  1/15 (6.67%)  0/15 (0.00%) 
Oropharyngeal Swelling  1  0/15 (0.00%)  0/15 (0.00%)  1/15 (6.67%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  1/15 (6.67%)  0/15 (0.00%)  1/15 (6.67%) 
Rash  1  0/15 (0.00%)  1/15 (6.67%)  1/15 (6.67%) 
Vascular disorders       
Hot Flush  1  1/15 (6.67%)  0/15 (0.00%)  0/15 (0.00%) 
Hypotension  1  0/15 (0.00%)  1/15 (6.67%)  0/15 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Development
Organization: Insys Therapeutics, Inc.
Phone: 480-500-3105
EMail: gdecastro@insysrx.com
Layout table for additonal information
Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT02915978     History of Changes
Other Study ID Numbers: INS002-16-092
First Submitted: September 23, 2016
First Posted: September 27, 2016
Results First Submitted: January 19, 2018
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018