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Trial record 9 of 56 for:    insys

Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pain

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ClinicalTrials.gov Identifier: NCT03254459
Recruitment Status : Completed
First Posted : August 18, 2017
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
INSYS Therapeutics Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: Buprenorphine Sublingual Spray
Drug: Morphine
Drug: Oxycodone Hydrochloride
Drug: Zofran
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Period Title: Overall Study
Started 50 50
Completed 40 27
Not Completed 10 23
Reason Not Completed
Adverse Event             7             20
Withdrawal by Subject Consent             3             1
Lost to Follow-up             0             1
Miscellaneous             0             1
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg Total
Hide Arm/Group Description

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Total of all reporting groups
Overall Number of Baseline Participants 50 50 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 100 participants
36.2  (10.83) 37.1  (11.68) 36.6  (11.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Female
48
  96.0%
48
  96.0%
96
  96.0%
Male
2
   4.0%
2
   4.0%
4
   4.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
Hispanic or Latino
17
  34.0%
14
  28.0%
31
  31.0%
Not Hispanic or Latino
33
  66.0%
36
  72.0%
69
  69.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 100 participants
American Indian or Alaska Native
3
   6.0%
0
   0.0%
3
   3.0%
Asian
3
   6.0%
0
   0.0%
3
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.0%
1
   1.0%
Black or African American
15
  30.0%
18
  36.0%
33
  33.0%
White
29
  58.0%
31
  62.0%
60
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE is an AE with onset that occurs after receiving study drug.
Time Frame Days 1 to 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, all participants who received study drug.
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description:

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
33
  66.0%
47
  94.0%
2.Secondary Outcome
Title Percentage of Participants Provided Rescue Medication for Nausea
Hide Description Zofran was used at the clinician's discretion as rescue medication for nausea.
Time Frame Days 1 to7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, all participants who received study drug.
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description:

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: percentage of participants
12 35
3.Secondary Outcome
Title Time to First Use of Rescue Medication for Nausea Following Each Dose of the Investigational Product (IP)
Hide Description Zofran was used at the clinician's discretion as rescue medication for nausea. Time "0" is defined as the time of the administration of study drug.
Time Frame Days 1 to 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, all participants who received study drug.
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description:

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Overall Number of Participants Analyzed 50 50
Median (95% Confidence Interval)
Unit of Measure: hours
NA [1] 
(NA to NA)
11.25
(5.60 to 23.13)
[1]
Data could not be calculated as more than 50% of subjects discontinued prior to Day 8.
4.Secondary Outcome
Title Total Use of Rescue Medication for Nausea Over 0 to 24 Hours, Over 0 to 48 Hours, Over 0-72 Hours and 0-7 Days
Hide Description Zofran was used at the clinician's discretion as rescue medication for nausea. The total use of rescue medication was calculated for the following 4 time-frames: 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days.
Time Frame 0 to 24 hours, 0 to 48 hours, 0 to 72 hours and 0 to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, all participants who received study drug.
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description:

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Overall Number of Participants Analyzed 50 50
Measure Type: Number
Unit of Measure: cumulative number of rescue doses
0 to 24 hours 9 68
0 to 48 hours 18 92
0 to 72 hours 22 110
0 to 7 days 42 152
5.Secondary Outcome
Title Pulse Oximetry Levels at 90 Minutes,12, 24, 48 and 72 Hours
Hide Description Pulse oximetry is a non-invasive method to measure a person's oxygen saturation.
Time Frame 90 Minutes,12, 24, 48 and 72 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, all participants who received study drug.
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description:

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Overall Number of Participants Analyzed 50 50
Mean (Standard Deviation)
Unit of Measure: percentage of oxygen saturation
90 minutes Number Analyzed 50 participants 50 participants
96.3  (1.99) 96.0  (2.11)
12 hours Number Analyzed 50 participants 49 participants
96.0  (1.93) 95.8  (2.06)
24 hours Number Analyzed 50 participants 48 participants
96.9  (1.63) 96.6  (2.27)
48 hours Number Analyzed 48 participants 46 participants
96.5  (2.01) 96.0  (2.15)
72 hours Number Analyzed 50 participants 50 participants
97.3  (1.36) 96.2  (2.66)
6.Secondary Outcome
Title Number of Participants With Abnormal Electrocardiograms (ECGs) Findings at 90 Minutes,12, 24, 48 and 72 Hours
Hide Description A standard 12-lead ECG will be performed after the participant is in the supine (lying face up) position for 5 minutes.
Time Frame Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, all participants who received study drug.
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description:

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-dose Number Analyzed 49 participants 49 participants
26
  53.1%
32
  65.3%
90 minutes Number Analyzed 50 participants 49 participants
33
  66.0%
30
  61.2%
12 hours Number Analyzed 50 participants 49 participants
31
  62.0%
34
  69.4%
24 hours Number Analyzed 49 participants 47 participants
23
  46.9%
29
  61.7%
48 hours Number Analyzed 48 participants 45 participants
18
  37.5%
25
  55.6%
72 hours Number Analyzed 42 participants 37 participants
14
  33.3%
18
  48.6%
7.Secondary Outcome
Title Number of Participants With Abnormal Oral Cavity Examinations
Hide Description Study staff will perform a sublingual (under the tongue) assessment, noting the color of mucosa and whether inflammation is present.
Time Frame Pre-dose and 90 minutes, 12, 24, 48 and 72 hours after first dose on Days 1 to 4 and End of Study Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population, all participants who received study drug.
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description:

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

Overall Number of Participants Analyzed 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-dose Number Analyzed 50 participants 50 participants
0
   0.0%
0
   0.0%
90 minutes Number Analyzed 49 participants 50 participants
0
   0.0%
0
   0.0%
12 hours Number Analyzed 50 participants 49 participants
0
   0.0%
0
   0.0%
24 hours Number Analyzed 50 participants 48 participants
0
   0.0%
0
   0.0%
48 hours Number Analyzed 46 participants 45 participants
0
   0.0%
1
   2.2%
72 hours Number Analyzed 43 participants 37 participants
0
   0.0%
0
   0.0%
Time Frame Screening to Day 8
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Hide Arm/Group Description

Morphine intravenous (IV), 4 mg TID for 24 hours, followed by oxycodone hydrochloride tablet, 10 mg TID for 6 days.

Morphine: Morphine

Oxycodone Hydrochloride: Oxycodone Hydrochloride 10 mg tablet

Buprenorphine Sublingual Spray 0.5 milligrams (mg) three times a day (TID) for 7 days.

Buprenorphine Sublingual Spray: Buprenorphine Sublingual Spray 0.5 mg

All-Cause Mortality
Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   1/50 (2.00%) 
General disorders     
Hematoma  1  0/50 (0.00%)  1/50 (2.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard of Care Narcotic Therapy Buprenorphine Sublingual Spray 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   33/50 (66.00%)   47/50 (94.00%) 
Gastrointestinal disorders     
Nausea  1  17/50 (34.00%)  39/50 (78.00%) 
Vomiting  1  6/50 (12.00%)  26/50 (52.00%) 
Constipation  1  4/50 (8.00%)  4/50 (8.00%) 
Nervous system disorders     
Dizziness  1  5/50 (10.00%)  11/50 (22.00%) 
Headache  1  8/50 (16.00%)  9/50 (18.00%) 
Somnolence  1  2/50 (4.00%)  3/50 (6.00%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  3/50 (6.00%)  14/50 (28.00%) 
Dyspnea  1  0/50 (0.00%)  4/50 (8.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  4/50 (8.00%)  8/50 (16.00%) 
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
Name/Title: Director, Clinical Development
Organization: Insys Therapeutics, Inc.
Phone: 4805003105
Responsible Party: INSYS Therapeutics Inc
ClinicalTrials.gov Identifier: NCT03254459     History of Changes
Other Study ID Numbers: INS005-17-111
First Submitted: August 16, 2017
First Posted: August 18, 2017
Results First Submitted: September 25, 2018
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018