Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
1 other identifier
interventional
101
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2012
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
January 26, 2015
CompletedJanuary 26, 2015
January 1, 2015
4 months
October 17, 2012
December 15, 2014
January 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 hours
Study Arms (3)
Sufentanil NanoTab 20 mcg
EXPERIMENTALSufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
Sufentanil NanoTab 30 mcg
EXPERIMENTALSufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
Placebo NanoTab
PLACEBO COMPARATORPlacebo NanoTab as needed every 60 minutes for 12 hours
Interventions
Eligibility Criteria
You may qualify if:
- patients scheduled for bunion surgery
You may not qualify if:
- daily opioid use
- drug or alcohol abuse
- pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Talphera, Inclead
Study Sites (2)
Lotus Clinical Research
Pasadena, California, United States
Jean Brown Research
Salt Lake City, Utah, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pamela Palmer, MD, PhD
- Organization
- AcelRx Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2012
First Posted
October 19, 2012
Study Start
October 1, 2012
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
January 26, 2015
Results First Posted
January 26, 2015
Record last verified: 2015-01