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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

Primary Purpose

Acute Moderate-to-severe Pain

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

sufentanil sublingual tablet 30 mcg

About this trial

This is an interventional treatment trial for Acute Moderate-to-severe Pain

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

HD Research
Research Concepts

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sufentanil sublingual tablet 30 mcg

Arm Description

sufentanil sublingual tablet 30 mcg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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)

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)

Full Information

NCT ID

NCT02662556

First Posted

January 20, 2016

Last Updated

January 25, 2017

Sponsor

AcelRx Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02662556

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AcelRx Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Moderate-to-severe Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sufentanil sublingual tablet 30 mcg

Arm Type

Experimental

Arm Description

sufentanil sublingual tablet 30 mcg

Intervention Type

Drug

Intervention Name(s)

sufentanil sublingual tablet 30 mcg

Other Intervention Name(s)

ST 30 mcg

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12-hours

Secondary Outcome Measure Information:

Title

Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).

Description

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.

Time Frame

1 hours

Title

Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good"

Description

Patients were asked "Overall, how would you rate the method of pain control"? Poor (1), Fair (2), Good (3), or Excellent (4)

Time Frame

12 hours or at patients' termination from study

Title

Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good"

Description

Healthcare professionals were asked "Overall, how would you rate the method of pain control"? Poor (1) Fair (2) Good (3) Excellent (4)

Time Frame

12 hours or until patients' termination from study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pamela P. Palmer, MD, PhD

Organizational Affiliation

AcelRx Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

HD Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

Facility Name

Research Concepts

City

Houston

State/Province

Texas

ZIP/Postal Code

77401

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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