Safety and Efficacy of Sufentanil NanoTab for Management of Acute Pain Following Bunionectomy
- Conditions
- Acute Pain
- Interventions
- Registration Number
- NCT01710345
- Lead Sponsor
- Talphera, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- patients scheduled for bunion surgery
- daily opioid use
- drug or alcohol abuse
- pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sufentanil NanoTab 30 mcg Sufentanil NanoTab 30 mcg Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours Placebo NanoTab Placebo NanoTab Placebo NanoTab as needed every 60 minutes for 12 hours Sufentanil NanoTab 20 mcg Sufentanil NanoTab 20 mcg Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
- Primary Outcome Measures
Name Time Method SPID-12 12 hours 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
Name Time Method
Trial Locations
- Locations (2)
Lotus Clinical Research
🇺🇸Pasadena, California, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States