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A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

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ClinicalTrials.gov Identifier: NCT02662556
Recruitment Status : Completed
First Posted : January 25, 2016
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
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 Acute Moderate-to-severe Pain
Intervention Drug: sufentanil sublingual tablet 30 mcg
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sufentanil Sublingual Tablet (SST) 30 mcg
Hide Arm/Group Description

Sufentanil sublingual tablet (SST) 30 mcg

Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Period Title: Overall Study
Started 140
Completed 132
Not Completed 8
Reason Not Completed
Adverse Event             4
Lack of Efficacy             4
Arm/Group Title Sufentanil Sublingual Tablet (SST) 30 mcg
Hide Arm/Group Description

Sufentanil sublingual tablet (SST) 30 mcg

Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Overall Number of Baseline Participants 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants
<=18 years
0
   0.0%
Between 18 and 65 years
116
  82.9%
>=65 years
24
  17.1%
[1]
Measure Description: All subjects must have been at least 40 years of age at the time of screening
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants
Female
75
  53.6%
Male
65
  46.4%
1.Primary Outcome
Title Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
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 throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
Time Frame 12-hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sufentanil Sublingual Tablet (SST) 30 mcg
Hide Arm/Group Description:

Sufentanil sublingual tablet (SST) 30 mcg

Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Overall Number of Participants Analyzed 137
Mean (Standard Error)
Unit of Measure: units on a scale
36.04  (2.22)
2.Secondary Outcome
Title Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).
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 throughout the 1 hour period. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The scores ranged from -6.67 to 6.77. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
Time Frame 1 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sufentanil Sublingual Tablet (SST) 30 mcg
Hide Arm/Group Description:

Sufentanil sublingual tablet (SST) 30 mcg

Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Overall Number of Participants Analyzed 137
Mean (Standard Error)
Unit of Measure: units on a scale
0.87  (0.16)
3.Secondary Outcome
Title Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good"
Hide Description Patients were asked "Overall, how would you rate the method of pain control"? Poor (1), Fair (2), Good (3), or Excellent (4)
Time Frame 12 hours or at patients' termination from study
Hide Outcome Measure Data
Hide Analysis Population Description
135 patients completed the scale
Arm/Group Title Sufentanil Sublingual Tablet (SST) 30 mcg
Hide Arm/Group Description:

Sufentanil sublingual tablet (SST) 30 mcg

Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Overall Number of Participants Analyzed 135
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
87.4
(81.81 to 93.00)
4.Secondary Outcome
Title Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good"
Hide Description Healthcare professionals were asked "Overall, how would you rate the method of pain control"? Poor (1) Fair (2) Good (3) Excellent (4)
Time Frame 12 hours or until patients' termination from study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sufentanil Sublingual Tablet (SST) 30 mcg
Hide Arm/Group Description:

Sufentanil sublingual tablet (SST) 30 mcg

Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Overall Number of Participants Analyzed 123
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of healthcare professionals
90.2
(85.00 to 95.49)
Time Frame Spontaneous reports throughout patients' participation in study through study completion.
Adverse Event Reporting Description SAEs were reported if occurrence was within 30 days of last dose of study medication.
 
Arm/Group Title Sufentanil Sublingual Tablet (SST) 30 mcg
Hide Arm/Group Description

Sufentanil sublingual tablet (SST) 30 mcg

Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

All-Cause Mortality
Sufentanil Sublingual Tablet (SST) 30 mcg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Sufentanil Sublingual Tablet (SST) 30 mcg
Affected / at Risk (%) # Events
Total   1/140 (0.71%)    
Nervous system disorders   
Acute Stroke * 1 [1]  1/140 (0.71%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
[1]
Occurred after patient's participation in study; Deemed unrelated to study drug
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Sufentanil Sublingual Tablet (SST) 30 mcg
Affected / at Risk (%) # Events
Total   45/140 (32.14%)    
Gastrointestinal disorders   
Nausea * 1 [1]  38/140 (27.14%) 
Investigations   
Oxygen saturation decreased * 1  3/140 (2.14%) 
Nervous system disorders   
Dizziness * 1  6/140 (4.29%) 
Headache * 1  4/140 (2.86%) 
Skin and subcutaneous tissue disorders   
Pruritis * 1  4/140 (2.86%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
[1]
Events entered in the list were noted as possibly or probably related to study drug
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pamela P. Palmer, MD, PhD, Chief Medical Officer
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: NCT02662556    
Other Study ID Numbers: SAP303
First Submitted: January 20, 2016
First Posted: January 25, 2016
Results First Submitted: November 7, 2016
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017