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Trial record 22 of 56 for:    insys

Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain

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ClinicalTrials.gov Identifier: NCT02310581
Recruitment Status : Terminated (Business decision)
First Posted : December 8, 2014
Results First Posted : August 9, 2017
Last Update Posted : August 9, 2017
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 Post-operative Pain
Interventions Drug: Buprenorphine Sublingual Spray
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Period Title: Overall Study
Started 9 11 10 10
Completed 6 9 9 9
Not Completed 3 2 1 1
Reason Not Completed
Adverse Event             1             1             1             0
Withdrawal by Subject             2             1             0             1
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo Total
Hide Arm/Group Description Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. Participants received placebo-matching buprenorphine sublingual spray four times daily for two days. Total of all reporting groups
Overall Number of Baseline Participants 9 11 10 10 40
Hide Baseline Analysis Population Description
All participants who were randomized.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 11 participants 10 participants 10 participants 40 participants
48.0
(31.0 to 65.0)
43.5
(26.0 to 65.0)
40.8
(28.0 to 61.0)
40.5
(19.0 to 61.0)
43.2
(19.0 to 65.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 11 participants 10 participants 10 participants 40 participants
Female
7
  77.8%
9
  81.8%
7
  70.0%
9
  90.0%
32
  80.0%
Male
2
  22.2%
2
  18.2%
3
  30.0%
1
  10.0%
8
  20.0%
1.Primary Outcome
Title Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
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 Baseline and 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 Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description:
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Overall Number of Participants Analyzed 9 11 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
169.621  (29.9942) 150.964  (27.5418) 129.133  (29.3429) 64.648  (29.0597)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine 0.5 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 104.973
Confidence Interval (2-Sided) 95%
25.13 to 184.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 39.2433
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Buprenorphine 1.0 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 86.316
Confidence Interval (2-Sided) 95%
9.94 to 162.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 37.5385
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Buprenorphine 1.0 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 64.485
Confidence Interval (2-Sided) 95%
-15.36 to 144.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 39.2459
Estimation Comments [Not Specified]
2.Secondary Outcome
Title NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours 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 up to 48 hours 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 timepoint 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.
Time Frame Baseline and 4, 8, 24 and 48 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the ITT Population with data available at each timepoint.
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description:
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Overall Number of Participants Analyzed 9 11 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
4 Hours Number Analyzed 9 participants 11 participants 10 participants 9 participants
4.7  (1.73) 3.4  (3.01) 3.8  (2.94) 1.6  (1.33)
8 Hours Number Analyzed 8 participants 11 participants 10 participants 9 participants
3.4  (1.41) 4.0  (2.97) 3.9  (2.28) 1.2  (1.99)
24 Hours Number Analyzed 6 participants 9 participants 9 participants 9 participants
5.5  (1.76) 3.0  (3.16) 3.4  (1.81) 2.6  (1.94)
48 Hours Number Analyzed 6 participants 9 participants 9 participants 9 participants
6.3  (1.03) 4.2  (2.39) 4.1  (2.80) 3.2  (2.64)
3.Secondary Outcome
Title NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours 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 up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.
Time Frame 4, 8, 24 and 48 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants from the ITT Population with data available at each timepoint.
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description:
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Overall Number of Participants Analyzed 9 11 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
4 Hours Number Analyzed 9 participants 11 participants 10 participants 9 participants
2.2  (2.49) 2.9  (3.08) 4.0  (2.87) 4.9  (3.14)
8 Hours Number Analyzed 8 participants 11 participants 10 participants 9 participants
3.5  (2.14) 2.3  (3.00) 3.9  (2.42) 5.2  (2.64)
24 Hours Number Analyzed 6 participants 9 participants 9 participants 9 participants
1.8  (1.47) 3.3  (2.55) 4.6  (2.07) 3.9  (2.80)
48 Hours Number Analyzed 6 participants 9 participants 9 participants 9 participants
1.0  (0.89) 2.1  (1.76) 3.9  (2.42) 3.2  (2.11)
4.Secondary Outcome
Title NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)
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 4 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-4 range is -40 to 40. The NRS SPID-4 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 Baseline and 0 to 4 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who were randomized.
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description:
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Overall Number of Participants Analyzed 9 11 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
11.430  (3.6221) 5.088  (3.3259) 7.095  (3.5434) -2.968  (3.5092)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine 0.5 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 14.398
Confidence Interval (2-Sided) 95%
4.76 to 24.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.7390
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Buprenorphine 1.0 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 8.056
Confidence Interval (2-Sided) 95%
-1.17 to 17.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.5331
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Buprenorphine 1.0 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 10.063
Confidence Interval (2-Sided) 95%
0.42 to 19.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.7393
Estimation Comments [Not Specified]
5.Secondary Outcome
Title NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)
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 8 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-8 range is -80 to 80. The NRS SPID-8 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 Baseline and 0 to 8 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants.
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description:
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Overall Number of Participants Analyzed 9 11 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
24.283  (6.2667) 19.223  (5.7543) 19.761  (6.1306) -2.382  (6.0715)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine 0.5 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0003
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 26.665
Confidence Interval (2-Sided) 95%
9.98 to 43.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.1991
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Buprenorphine 1.0 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 21.605
Confidence Interval (2-Sided) 95%
5.65 to 37.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.8429
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Buprenorphine 1.0 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 22.143
Confidence Interval (2-Sided) 95%
5.46 to 38.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.1997
Estimation Comments [Not Specified]
6.Secondary Outcome
Title NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)
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 24 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-24 range is -240 to 240. The NRS SPID-24 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 Baseline and 0 to 24 hours after Time 0
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who were randomized.
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description:
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Overall Number of Participants Analyzed 9 11 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
83.668  (14.0612) 70.071  (12.9115) 76.666  (13.7558) 19.787  (13.6231)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Buprenorphine 0.5 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 63.881
Confidence Interval (2-Sided) 95%
26.45 to 101.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 18.3971
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Buprenorphine 1.0 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 50.284
Confidence Interval (2-Sided) 95%
14.48 to 86.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 17.5979
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Buprenorphine 1.0 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments The analysis included treatment and site as main effects and Baseline pain intensity as the covariate.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 56.879
Confidence Interval (2-Sided) 95%
19.45 to 94.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 18.3984
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants Who Used Rescue Medication for Pain
Hide Description The percentage of participants who needed to take an alternate medication for pain relief during the study.
Time Frame From Time 0 (first dose of study drug) up to Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who were randomized.
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description:
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
Overall Number of Participants Analyzed 9 11 10 10
Measure Type: Number
Unit of Measure: percentage of participants
44.4 54.5 60.0 100
Time Frame Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Hide Arm/Group Description Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days. Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days. Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days. Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
All-Cause Mortality
Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/9 (11.11%)   0/11 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Cardiac disorders         
Atrial fibrillation  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Buprenorphine 0.5 mg TID Buprenorphine 1.0 mg BID Buprenorphine 1.0 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/9 (100.00%)   11/11 (100.00%)   9/10 (90.00%)   7/10 (70.00%) 
Eye disorders         
Visual disturbance  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders         
Burning mouth  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Constipation  1  0/9 (0.00%)  3/11 (27.27%)  2/10 (20.00%)  0/10 (0.00%) 
Diarrhea  1  0/9 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Dry mouth  1  1/9 (11.11%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Dysphagia  1  1/9 (11.11%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Emesis  1  4/9 (44.44%)  5/11 (45.45%)  5/10 (50.00%)  0/10 (0.00%) 
Heartburn  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Loose stools  1  0/9 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Nausea  1  7/9 (77.78%)  10/11 (90.91%)  7/10 (70.00%)  3/10 (30.00%) 
Numbness mouth  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Sore mouth  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Tingling lips  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Tingling tongue  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Vomiting  1  2/9 (22.22%)  3/11 (27.27%)  3/10 (30.00%)  0/10 (0.00%) 
Xerostomia  1  0/9 (0.00%)  2/11 (18.18%)  0/10 (0.00%)  0/10 (0.00%) 
General disorders         
Feeling hot  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Shivering  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Infections and infestations         
Cellulitis  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Post procedural cellulitis  1  0/9 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Injury, poisoning and procedural complications         
Incision site erythema  1  0/9 (0.00%)  0/11 (0.00%)  2/10 (20.00%)  0/10 (0.00%) 
Investigations         
Oxygen saturation decreased  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Respiratory rate decreased  1  0/9 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Temperature elevation  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Metabolism and nutrition disorders         
Anorexia  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Dehydration  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Musculoskeletal and connective tissue disorders         
Cramps in leg  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Low back pain  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Nervous system disorders         
Dizziness  1  5/9 (55.56%)  4/11 (36.36%)  4/10 (40.00%)  0/10 (0.00%) 
Dizzy  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Drowsiness  1  4/9 (44.44%)  3/11 (27.27%)  4/10 (40.00%)  0/10 (0.00%) 
Dysgeusia  1  0/9 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Headache  1  1/9 (11.11%)  4/11 (36.36%)  1/10 (10.00%)  2/10 (20.00%) 
Intermittent headache  1  0/9 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  2/10 (20.00%) 
Lightheadedness  1  2/9 (22.22%)  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%) 
Paresthesia of fingers  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Shakiness  1  0/9 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Trembling  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Psychiatric disorders         
Confusion  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Euphoria  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Vivid dreams  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Renal and urinary disorders         
Urinary retention  1  0/9 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/9 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Hiccups  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Singultus  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders         
Adhesive tape allergy  1  0/9 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Diaphoresis  1  2/9 (22.22%)  2/11 (18.18%)  1/10 (10.00%)  0/10 (0.00%) 
Itching  1  1/9 (11.11%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Localised rash  1  0/9 (0.00%)  0/11 (0.00%)  1/10 (10.00%)  1/10 (10.00%) 
Pruritus  1  1/9 (11.11%)  1/11 (9.09%)  1/10 (10.00%)  0/10 (0.00%) 
Pruritus facial  1  1/9 (11.11%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Wheals  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Vascular disorders         
Flushing  1  0/9 (0.00%)  1/11 (9.09%)  0/10 (0.00%)  0/10 (0.00%) 
Hot flush  1  1/9 (11.11%)  2/11 (18.18%)  0/10 (0.00%)  0/10 (0.00%) 
Hypertension  1  0/9 (0.00%)  0/11 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Pallor  1  1/9 (11.11%)  0/11 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
This study was terminated early by the sponsor due to business reasons (40 participants enrolled out of 312 planned). Due to this early termination 10 outcome measures originally registered as pre-specified secondary are no longer secondaries.
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: NCT02310581     History of Changes
Other Study ID Numbers: INS-14-026
First Submitted: December 1, 2014
First Posted: December 8, 2014
Results First Submitted: June 1, 2017
Results First Posted: August 9, 2017
Last Update Posted: August 9, 2017