Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Overall Performance of the Zalviso System™ (Sufentanil Sublingual Tablet System) 15 mcg

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: NCT02662764
Recruitment Status : Completed
First Posted : January 26, 2016
Results First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Moderate-to-severe Acute Pain
Intervention Drug: Zalviso™ 15 mcg
Enrollment 320
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Period Title: Overall Study
Started 320
Completed 290 [1]
Not Completed 30
Reason Not Completed
Adverse Event             6
Lack of Efficacy             8
Protocol Violation             1
Withdrawal by Subject             5
Device failure             4
Patient changed treatment             1
Patient discharged prior to 24 hrs             5
[1]
First 24-hours of study treatment
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
Overall Number of Baseline Participants 320
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age, Customized Number Analyzed 320 participants
<65
198
  61.9%
> or equal to 65
122
  38.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants
Female
193
  60.3%
Male
127
  39.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants
Hispanic or Latino
18
   5.6%
Not Hispanic or Latino
302
  94.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 320 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   0.6%
Native Hawaiian or Other Pacific Islander
1
   0.3%
Black or African American
35
  10.9%
White
280
  87.5%
More than one race
1
   0.3%
Unknown or Not Reported
1
   0.3%
1.Primary Outcome
Title Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of patients
2.2
2.Primary Outcome
Title Percentage of Patients, if Any, With Tablets Dispensed But Not Requested
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:

Zalviso™(sufentanil sublingual tablet system) 15 mcg

Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for up to 72 hours

Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of patients
0
3.Primary Outcome
Title Percentage of Patients, if Any, With Tablet Dispensed When the Zalviso System Was in Lockout
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:

Zalviso™(sufentanil sublingual tablet system) 15 mcg

Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours

Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of patients
0
4.Primary Outcome
Title Percentage of Patients With Misplaced Tablet(s)
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of patients
3.8
5.Primary Outcome
Title Number of Misplaced Tablets (i.e., Tablet Found Outside the Patient's Mouth)
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: tablets
13
6.Primary Outcome
Title Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet (i.e., a Dispense Failure)
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of patients
5.6
7.Primary Outcome
Title Number of Zalviso System Notifications to the Nurse to Retrain Patient to Not Pull Down on the Controller While Dosing
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: Notifications
0
8.Primary Outcome
Title Percentage of Patients Who Experienced at Least One System-generated Error Based on the Controller Data While Using the Zalviso System
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:

Zalviso™(sufentanil sublingual tablet system) 15 mcg

Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for up to 72 hours

Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of patients
2.2
9.Primary Outcome
Title Percentage of Patients Who Experienced Either a System-generated Error or a Misplaced Tablet That Caused an Analgesic Gap
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of participants
2.8
10.Primary Outcome
Title Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent"
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of patients
86.1
11.Primary Outcome
Title Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of patients
88.5
12.Primary Outcome
Title Percentage of Patients Who Rate the Patient Global Assessment (PGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage of patients
100
13.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Poor" at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: percentage of patients
1.4
14.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Fair" at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: percentage of patients
12.6
15.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Good" at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: percentage of patients
40.8
16.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) as "Excellent" at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 294
Measure Type: Number
Unit of Measure: percentage of patients
45.2
17.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Poor"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of patients
0.9
18.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Fair"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of patients
10.6
19.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Good"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of patients
41.6
20.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 48 Hours as "Excellent"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 113
Measure Type: Number
Unit of Measure: percentage of patients
46.9
21.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Poor"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage of patients
0
22.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Fair"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage of patients
0
23.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Good"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by subjects who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage of patients
42.9
24.Primary Outcome
Title Percentage of Patients Who Responded to the Patient Global Assessment (PGA) at 72 Hours as "Excellent"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage of patients
57.1
25.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 24 Hours as "Good" or "Excellent"
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 270
Measure Type: Number
Unit of Measure: percentage of HCPs
91.1
26.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Rate the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 48 Hours as "Good" or "Excellent"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of HCPs
95.1
27.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Rated the Healthcare Professional Global Assessment (HPGA) of Method of Pain Control Over 72 Hours as "Good" or "Excellent"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. In rare cases, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of HCPs
100
28.Primary Outcome
Title Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Poor" at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 270
Measure Type: Number
Unit of Measure: percentage of HCPs
0.7
29.Primary Outcome
Title Percentage of Healthcare Professional Global Assessment (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Fair" at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 270
Measure Type: Number
Unit of Measure: percentage of HCPs
8.1
30.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Good" at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 270
Measure Type: Number
Unit of Measure: percentage of HCPs
38.9
31.Primary Outcome
Title Percentage of Healthcare Professional (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) as "Excellent" at 24 Hours
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 270
Measure Type: Number
Unit of Measure: percentage of HCPs
52.2
32.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Poor"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of HCPs
1.0
33.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Fair"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of HCPs
3.9
34.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA )at 48 Hours as "Good"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of HCPs
27.5
35.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 48 Hours as "Excellent"
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of HCPs
67.6
36.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Poor"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of HCPs
0
37.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Fair"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for at least 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of HCPs
0
38.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Good"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of HCPs
8.3
39.Primary Outcome
Title Percentage of Healthcare Professionals (HCPs) Who Responded to the Healthcare Professional Global Assessment (HPGA) at 72 Hours as "Excellent"
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of HCPs who completed the assessment. On rare occasions, the HCP did not complete the assessment in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of HCPs
91.7
40.Primary Outcome
Title Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Over the 24-hour Study Period
Hide Description [Not Specified]
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 320
Measure Type: Number
Unit of Measure: percentage of patients
2.5
41.Primary Outcome
Title Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia After the 24-hour Study Period and Prior to or During the 48 Hour Study Period
Hide Description [Not Specified]
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 290
Measure Type: Number
Unit of Measure: percentage of patients
2.8
42.Primary Outcome
Title Percentage of Patients Who Terminated From the Study Due to Inadequate Analgesia Prior to or During the 72 Hour Study Period
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 93
Measure Type: Number
Unit of Measure: percentage of patients
0
43.Primary Outcome
Title Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24)
Hide Description The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 24 hour period. The time-weighted SPID24 is the time-weighted summed PID over the 24-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from - 72 to 204.
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 313
Mean (Standard Error)
Unit of Measure: units on a scale
63.09  (2.58)
44.Primary Outcome
Title Time-weighted Summed Pain Intensity Difference (SPID) Over the 48-hour Study Period (SPID-48) Study Period
Hide Description The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points and throughout the 48 hour period. The time-weighted SPID48 is the time-weighted summed PID over the 48-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.The scores ranged from -144 to 408.
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 313
Mean (Standard Error)
Unit of Measure: units on a scale
130.69  (5.56)
45.Primary Outcome
Title Time-weighted Summed Pain Intensity Difference (SPID) Over the 72-hour Study Period (SPID-72) Study Period
Hide Description The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and at protocol-specified time points throughout the 72 hour period. The time-weighted SPID72 is the time-weighted summed PID over the 72-hour study period. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. The scores ranged from -239 to 624.
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 313
Mean (Standard Error)
Unit of Measure: units on a scale
204.66  (8.61)
46.Primary Outcome
Title Total Pain Relief (TOTPAR) Over the 24-hour Study Period (TOTPAR24)
Hide Description Total pain relief over the 24-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 96.00.
Time Frame Up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 318
Mean (Standard Error)
Unit of Measure: units on a scale
54.27  (1.14)
47.Primary Outcome
Title Total Pain Relief (TOTPAR) Over the 48-hour Study Period (TOTPAR48)
Hide Description Total pain relief over the 48-hour study period. A higher TOTPAR score means a greater relief in pain. Range of scores was from 0.00 to 192.00.
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 318
Mean (Standard Error)
Unit of Measure: units on a scale
111.42  (2.35)
48.Primary Outcome
Title Total Pain Relief (TOTPAR) Over the 72-hour Study Period (TOTPAR72)
Hide Description Total pain relief over the 72-hour study period. A higher TOTPAR means a greater relief in pain. Range of scores was from 0.00 to 288.00.
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 318
Mean (Standard Error)
Unit of Measure: units on a scale
171.10  (3.70)
49.Primary Outcome
Title Pain Intensity (PI) at Each Evaluation Time Point
Hide Description At protocol-specified time points, the patient is asked to self-record his/her current level of pain on an 11-point numerical rating scale where 0 equals no pain and 10 equals the worst possible pain.
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 313
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 5.84  (0.07)
15 minutes 4.77  (0.13)
30 minutes 4.46  (0.13)
45 minutes 4.05  (0.13)
1 hour 3.70  (0.13)
2 hours 3.37  (0.12)
4 hours 3.39  (0.12)
6 hours 3.20  (0.12)
8 hours 3.18  (0.13)
10 hours 3.10  (0.13)
12 hours 2.97  (0.12)
16 hours 3.08  (0.13)
20 hours 3.20  (0.14)
24 hours 3.16  (0.13)
28 hours 3.16  (0.13)
32 hours 3.15  (0.13)
36 hours 3.06  (0.13)
40 hours 2.96  (0.13)
44 hours 2.93  (0.13)
48 hours 2.82  (0.13)
52 hours 2.76  (0.12)
56 hours 2.77  (0.12)
60 hours 2.75  (0.12)
64 hours 2.76  (0.12)
68 hours 2.77  (0.12)
72 hours 2.76  (0.12)
50.Primary Outcome
Title Pain Intensity Difference (PID) at Each Evaluation Time Point
Hide Description The PID at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. The higher the PID score, the lower the pain intensity. The scores ranged from - 239 to 624.
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 313
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 5.84  (0.07)
15 minutes 1.07  (0.10)
30 minutes 1.38  (0.10)
45 minutes 1.79  (0.11)
1 hour 2.14  (0.11)
2 hours 2.48  (0.12)
4 hours 2.45  (0.13)
6 hours 2.64  (0.12)
8 hours 2.67  (0.13)
10 hours 2.74  (0.13)
12 hours 2.88  (0.12)
16 hours 2.77  (0.13)
20 hours 2.65  (0.14)
24 hours 2.69  (0.14)
28 hours 2.68  (0.14)
32 hours 2.69  (0.14)
36 hours 2.78  (0.14)
40 hours 2.88  (0.14)
44 hours 2.91  (0.14)
48 hours 3.02  (0.14)
52 hours 3.08  (0.14)
56 hours 3.08  (0.13)
60 hours 3.09  (0.14)
64 hours 3.08  (0.13)
68 hours 3.08  (0.13)
72 hours 3.08  (0.13)
51.Primary Outcome
Title Pain Relief (PR) at Each Evaluation Time Point
Hide Description At protocol-specified time points, the patient is asked to self-record his/her current level of pain relief on 5-point numerical rating scale where 0 equaled no pain relief and 4 equaled complete pain relief. The baseline score references the baseline pain intensity score and the following timepoints reference pain relief scores.
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was completed by patients who were not sleeping at the time of the assessment, had not withdrawn prematurely, or for whom the assessment was not done in error.
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 318
Mean (Standard Error)
Unit of Measure: units on a scale
(Not Applicable) Number Analyzed 312 participants
NA [1]   (NA)
15 minutes Number Analyzed 310 participants
1.18  (0.07)
30 minutes Number Analyzed 317 participants
1.42  (0.06)
45 minutes Number Analyzed 317 participants
1.67  (0.06)
1 hour Number Analyzed 317 participants
1.81  (0.07)
2 hours Number Analyzed 318 participants
2.08  (0.06)
4 hours Number Analyzed 318 participants
2.12  (0.06)
6 hours Number Analyzed 318 participants
2.24  (0.06)
8 hours Number Analyzed 318 participants
2.24  (0.06)
10 hours Number Analyzed 318 participants
2.32  (0.06)
12 hours Number Analyzed 318 participants
2.37  (0.06)
16 hours Number Analyzed 318 participants
2.31  (0.06)
20 hours Number Analyzed 318 participants
2.30  (0.06)
24 hours Number Analyzed 318 participants
2.42  (0.06)
28 hours Number Analyzed 318 participants
2.37  (0.06)
32 hours Number Analyzed 318 participants
2.34  (0.06)
36 hours Number Analyzed 318 participants
2.34  (0.06)
40 hours Number Analyzed 318 participants
2.39  (0.06)
44 hours Number Analyzed 318 participants
2.41  (0.06)
48 hours Number Analyzed 318 participants
2.44  (0.06)
52 hours Number Analyzed 318 participants
2.48  (0.06)
56 hours Number Analyzed 318 participants
2.48  (0.06)
60 hours Number Analyzed 318 participants
2.49  (0.06)
64 hours Number Analyzed 318 participants
2.48  (0.06)
68 hours Number Analyzed 318 participants
2.49  (0.06)
72 hours Number Analyzed 318 participants
2.50  (0.06)
[1]
Pain relief was not collected at baseline since the patient had not yet received study drug
52.Primary Outcome
Title Patient Usability Questionnaire (PUQ)
Hide Description Questionnaire completed by patients at the end of his/her participation in the study regarding the usability of Zalviso.
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 317
Measure Type: Number
Unit of Measure: percentage of patients
Agreed Zalviso was easy to use 90.5
Agreed having confidence to dose 92.4
Agreed Zalviso worked consistently as expected 82.3
Agreed they knew how to use Zalviso 93.4
Agreed they knew what to do if a tablet dropped 86.1
Agreed Zalviso instructions were explained 91.2
Agreed to request Zalviso after next surgery 80.4
53.Primary Outcome
Title Nurse Usability Questionnaire (NUQ)
Hide Description Questionnaire regarding the usability of Zalviso completed by HCPs who had set up at least 5 Zalviso Systems for patients
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: percentage of HCPs
Agreed Zalviso easy to set up 92.5
Agreed had confidence to set up Zalviso 92.5
Agreed no need to trouble-shoot during patient use 87.5
Agreed with appropriate tablet accountability 100
Agreed Zalviso was not time-consuming to set up 72.5
Agreed Zalviso instructions were clear 90
Would recommend using Zalviso 87.5
54.Primary Outcome
Title Number of Study Drug Doses Used
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 320
Mean (Standard Deviation)
Unit of Measure: doses
24-hour treatment period 15.7  (9.9)
48-hour treatment period 21.9  (14.8)
72-hour treatment period 22.8  (15.7)
55.Primary Outcome
Title Average Hourly Use of Study Drug
Hide Description Average number of study drug doses used per hour, adjusting by treatment exposure time and study period
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 320
Mean (Standard Deviation)
Unit of Measure: average number of study doses per hour
0.82  (0.51)
56.Primary Outcome
Title Average Inter-dosing Interval (in Minutes)
Hide Description [Not Specified]
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours.
Overall Number of Participants Analyzed 316
Mean (Standard Deviation)
Unit of Measure: average interval (minutes) between doses
24-hour study period 121.4  (116.2)
48-hour study period 123.2  (151.6)
72-hour study period 120.9  (109.7)
57.Primary Outcome
Title Total Amount of Supplemental Morphine (mg) Utilized
Hide Description Supplemental opioid medication (2 mg IV morphine) was allowed in the first 30 minutes after the first on-demand dose of study drug had been administered, if necessary, to keep a patient comfortable. Otherwise, supplemental opioid medication (2 mg IV morphine, no more frequently than hourly) was allowed for pain due to ambulation or with the initiation of passive range of motion therapy throughout the remainder of the study.
Time Frame Up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Amount of supplemental morphine (mg) utilized by patients
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description:
Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours.
Overall Number of Participants Analyzed 320
Mean (Standard Deviation)
Unit of Measure: amount of morphine (mg) used
0.1  (0.4)
Time Frame From the time of first study medication dose through 72 hours, including those reported 12 hours after the last dose was taken
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zalviso™ 15 mcg
Hide Arm/Group Description Zalviso™ 15 mcg: Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
All-Cause Mortality
Zalviso™ 15 mcg
Affected / at Risk (%)
Total   0/320 (0.00%)    
Hide Serious Adverse Events
Zalviso™ 15 mcg
Affected / at Risk (%) # Events
Total   3/320 (0.94%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/320 (0.31%)  1
Cardiac disorders   
Cardiac Failure Chronic * 1  1/320 (0.31%)  1
General disorders   
Pyrexia * 1  1/320 (0.31%)  1
Injury, poisoning and procedural complications   
Renal Injury * 1  1/320 (0.31%)  1
Nervous system disorders   
Sedation * 1  1/320 (0.31%)  1
Renal and urinary disorders   
Chronic renal failure * 1  1/320 (0.31%)  1
Vascular disorders   
Hypotension * 1  1/320 (0.31%)  1
Labile blood pressure * 1  1/320 (0.31%)  1
1
Term from vocabulary, MedDRA (11.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Zalviso™ 15 mcg
Affected / at Risk (%) # Events
Total   190/320 (59.38%)    
Cardiac disorders   
Bradycardia * 1  17/320 (5.31%)  34
Tachycardia * 1  8/320 (2.50%)  8
Gastrointestinal disorders   
Nausea * 1  84/320 (26.25%)  88
Vomiting * 1  32/320 (10.00%)  49
Constipation * 1  8/320 (2.50%)  8
General disorders   
Pyrexia * 1  10/320 (3.13%)  10
Investigations   
Oxygen saturation decreased * 1  19/320 (5.94%)  25
Metabolism and nutrition disorders   
Hypokalaemia * 1  14/320 (4.38%)  14
Musculoskeletal and connective tissue disorders   
Muscle spasms * 1  25/320 (7.81%)  25
Nervous system disorders   
Dizziness * 1  14/320 (4.38%)  16
Headache * 1  12/320 (3.75%)  13
Skin and subcutaneous tissue disorders   
Pruritis * 1  11/320 (3.44%)  11
Vascular disorders   
Hypotension * 1  36/320 (11.25%)  113
Hypertension * 1  7/320 (2.19%)  7
1
Term from vocabulary, MedDRA (11.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Investigator must obtain approval from AcelRx in order to discuss or publish trial results
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pamela Palmer, MD, PhD
Organization: AcelRx Pharmaceuticals, Inc
Phone: 650-216-3504
EMail: ppalmer@acelrx.com
Layout table for additonal information
Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02662764    
Other Study ID Numbers: IAP312
First Submitted: January 20, 2016
First Posted: January 26, 2016
Results First Submitted: April 13, 2018
Results First Posted: August 8, 2018
Last Update Posted: August 8, 2018