Back to resultsSafety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sufentanil NanoTab 20 mcg
Sufentanil NanoTab 30 mcg
Placebo NanoTab
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
- patients scheduled for bunion surgery
Exclusion Criteria:
- daily opioid use
- drug or alcohol abuse
- pregnant or breastfeeding women
Sites / Locations
- Lotus Clinical Research
- Jean Brown Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Sufentanil NanoTab 20 mcg
Sufentanil NanoTab 30 mcg
Placebo NanoTab
Arm Description
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
Placebo NanoTab as needed every 60 minutes for 12 hours
Outcomes
Primary Outcome Measures
SPID-12
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.
The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
Secondary Outcome Measures
Full Information
NCT ID
NCT01710345
First Posted
October 17, 2012
Last Updated
January 23, 2015
Sponsor
AcelRx Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01710345
Brief Title
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AcelRx Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
This is a dose-finding study to determine if the sublingual administration of the Sufentanil NanoTab is safe and effective in the treatment of post-operative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sufentanil NanoTab 20 mcg
Arm Type
Experimental
Arm Description
Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
Arm Title
Sufentanil NanoTab 30 mcg
Arm Type
Experimental
Arm Description
Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
Arm Title
Placebo NanoTab
Arm Type
Placebo Comparator
Arm Description
Placebo NanoTab as needed every 60 minutes for 12 hours
Intervention Type
Drug
Intervention Name(s)
Sufentanil NanoTab 20 mcg
Intervention Type
Drug
Intervention Name(s)
Sufentanil NanoTab 30 mcg
Intervention Type
Drug
Intervention Name(s)
Placebo NanoTab
Primary Outcome Measure Information:
Title
SPID-12
Description
The primary outcome measure is the summed pain intensity difference over the 12-hour study period (SPID-12). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour study period. The SPID-12 is calculated by summing the difference between baseline pain score and pain score at each assessment time point.
The SPID-12 ranges from -120 (indicative of an increase in pain) to 120 (indicative of a decrease in pain). A higher SPID-12 score is better.
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled for bunion surgery
Exclusion Criteria:
daily opioid use
drug or alcohol abuse
pregnant or breastfeeding women
Facility Information:
Facility Name
Lotus Clinical Research
City
Pasadena
State/Province
California
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
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