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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Detailed Description

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.

Interventions

  • Drug: sufentanil sublingual tablet 30 mcg
    • sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Arms, Groups and Cohorts

  • Experimental: sufentanil sublingual tablet 30 mcg
    • sufentanil sublingual tablet 30 mcg

Clinical Trial Outcome Measures

Primary Measures

  • Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
    • Time Frame: 12-hours
    • 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.

Secondary Measures

  • Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).
    • Time Frame: 1 hours
    • 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.
  • Percentage of Patients Who Responded to the Global Assessments as “Excellent” or “Good”
    • Time Frame: 12 hours or at patients’ termination from study
    • Patients were asked “Overall, how would you rate the method of pain control”? Poor (1), Fair (2), Good (3), or Excellent (4)
  • Percentage of Healthcare Professionals Who Responded to the Global Assessments as “Excellent” or “Good”
    • Time Frame: 12 hours or until patients’ termination from study
    • Healthcare professionals were asked “Overall, how would you rate the method of pain control”? Poor (1) Fair (2) Good (3) Excellent (4)

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female patients who are 40 years of age or older.

2. Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.

3. Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I).

Exclusion Criteria

1. 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).

2. Patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication.

3. 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.

4. Patients who have used any illicit drugs of abuse within five years before the start of the study.

5. Patients who have abused any prescription medication or alcohol within one year before the start of the study.

6. Patients with an allergy or hypersensitivity to opioids.

7. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.

8. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AcelRx Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pamela P. Palmer, MD, PhD, Study Director, AcelRx Pharmaceuticals, Inc.

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