A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

Study Overview
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Brief Summary
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This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Detailed Description
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This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Upon meeting all entrance criteria, patients will be administered the first dose of ST 30 mcg and will remain in the study for up to 12 hours for safety and efficacy measurements. Patients may receive additional doses of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes.

Official Title
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A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

Conditions
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Acute Moderate-to-severe Pain

Intervention / Treatment
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* Drug: sufentanil sublingual tablet 30 mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients who are 40 years of age or older. Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I). Exclusion Criteria: 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 (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet). Patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication. Patients with a history of opioid dependence within 2 years before the start of the study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified in Appendix II. Patients who have used any illicit drugs of abuse within five years before the start of the study. Patients who have abused any prescription medication or alcohol within one year before the start of the study. Patients with an allergy or hypersensitivity to opioids. 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).

Ages Eligible for Study
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Minimum Age: 40 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sufentanil sublingual tablet 30 mcg<br>sufentanil sublingual tablet 30 mcg | Drug: sufentanil sublingual tablet 30 mcg<br>* sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.<br>* Other names: ST 30 mcg;|

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 pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. 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 First Hour (SPID1). | The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity [PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 1 hour period. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The scores ranged from -6.67 to 6.77. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity. | 1 hours | 
| Percentage of Patients Who Responded to the Global Assessments as Excellent or Good | Patients were asked Overall, how would you rate the method of pain control? Poor (1), Fair (2), Good (3), or Excellent (4) | 12 hours or at patients' termination from study | 
| Percentage of Healthcare Professionals Who Responded to the Global Assessments as Excellent or Good | Healthcare professionals were asked Overall, how would you rate the method of pain control? Poor (1) Fair (2) Good (3) Excellent (4) | 12 hours or until patients' termination from study |