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

January 25, 2017 updated by: AcelRx Pharmaceuticals, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77401
        • HD Research
      • Houston, Texas, United States, 77401
        • Research Concepts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sufentanil sublingual tablet 30 mcg
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.
Other Names:
  • ST 30 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hours
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)
12 hours or at patients' termination from study
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)
12 hours or until patients' termination from study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AcelRx Pharmaceuticals, Inc.

Investigators

  • Study Director: Pamela P. Palmer, MD, PhD, AcelRx Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAP303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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