A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for the Treatment of Post-Operative Pain in Patients After Abdominal Surgery

Conditions
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Post-Operative Pain

Intervention / Treatment
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* Drug: Sufentanil Tablet 30 mcg
* Drug: Placebo Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (additional criteria not specified here): Patients who are scheduled to undergo one of the following procedures with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation: abdominoplasty open tension-free inguinal hernioplasty (Lichenstein repair with mesh) laparoscopic abdominal surgery Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I). Female patients of childbearing potential must be using an effective method of birth control at the time of screening visit Patients who are expected to have moderate-to-severe post-operative pain for at least 24 hours. Exclusion Criteria (additional criteria not specified here): Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP). Patients who previously have had abdominoplasty or have had an inguinal hernia repair on the same side.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil Tablet 30 mcg<br>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. | Drug: Sufentanil Tablet 30 mcg<br> <br> * Other names: ST 30 mcg;|
| Placebo Comparator: Placebo Tablet<br>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. | Drug: Placebo Tablet<br> <br> * Other names: PT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). | 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. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). | 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. | 24 hours | 
| TOTPAR12 | 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. | 12 hours | 
| TOTPAR24 | 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. | 24 Hours | 
| Time-weighted SPRID12 | 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. | 12 hours | 
| Time-weighted SPRID24 | 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. | 24 hours | 
| Patient Global Assessment | Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours | 24 hours | 
| Healthcare Professional Global Assessment | Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours | 24 hours | 
| Summed Pain Intensity Difference | 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. | 1 hour | 
| 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 | 
| Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population |  | Cumulative through 6 hours | 
| Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population |  | Cumulative through 12 hours | 
| Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population |  | Cumulative through 24 hours |