A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
- Conditions
- Post-Operative Pain
- Interventions
- Drug: Placebo Tablet
- Registration Number
- NCT02356588
- Lead Sponsor
- Talphera, Inc
- Brief Summary
The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of moderate-to-severe acute post-operative pain in patients after abdominal surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Tablet Placebo Tablet A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours. Sufentanil Tablet 30 mcg Sufentanil Tablet 30 mcg A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.
- Primary Outcome Measures
Name Time Method Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). 12 hours The primary outcome measure is the summed pain intensity difference to baseline 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 observed SPID-12 scores ranged from -42.15 to 71.87 in the active group and -34.96 to 64.37 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
- Secondary Outcome Measures
Name Time Method TOTPAR24 24 Hours Total pain relief over the 24 hour study period. The observed total pain relief scores ranged from 12.35 to 95.23 in the active group and 2.61 to 82.04 in the placebo group. A higher score indicates greater pain relief.
Time-weighted SPRID12 12 hours Time-weighted summed pain relief intensity difference (SPRID) over the 12 hour study period. The observed SPRID scores ranged from -38.08 to 106.82 in the active group and -20.10 to 95.72 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.
Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). 24 hours The primary outcome measure is the summed pain intensity difference to baseline over the 24-hour study period (SPID-24). A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 24 hour study period. The SPID-24 is calculated by summing the difference between baseline pain score and pain score at each assessment time point. The observed SPID-24 scores ranged from -70.00 to 148.70 in the active group to -58.09 to 160.24 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.
TOTPAR12 12 hours Total pain relief over the 12 hours. The observed total pain relief scores ranged from 4.08 to 47.50 in the active group and 1.77 to 33.71 in the placebo group. A higher score indicates greater pain relief.
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population Cumulative through 24 hours Time-weighted SPRID24 24 hours Time-weighted summed pain relief intensity difference (SPRID) over the 24 hour study period. The observed SPRID scores ranged from -49.67 to 222.04 in the active group and -24.97 to 237.54 in the placebo group. A negative score indicates an increase in pain intensity and decrease in pain relief, while a higher score indicates a greater decrease in pain intensity and increase in pain relief.
Patient Global Assessment 24 hours Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours
Healthcare Professional Global Assessment 24 hours Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours
Summed Pain Intensity Difference 1 hour The SPID-1 is calculated by summing the difference to baseline between baseline pain score and the pain score at each assessment time point through 1 hour.
The observed SPID scores ranged from -2.00 to 5.25 in the active group to -4.90 to 3.00 in the placebo group. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population Cumulative through 12 hours Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population 24 hours
Trial Locations
- Locations (4)
Shoals Medical Trials, Inc
🇺🇸Sheffield, Alabama, United States
Lotus Clinical Research
🇺🇸Pasadena, California, United States
Victory Medical Center
🇺🇸Houston, Texas, United States
Research Concepts, LLC
🇺🇸Houston, Texas, United States