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

Primary Purpose

Post-Operative Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sufentanil Tablet 30 mcg
Placebo Tablet
Sponsored by
AcelRx Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Operative Pain

Eligibility Criteria

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

Inclusion Criteria (additional criteria not specified here):

  1. 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
  2. Patients classified as American Society of Anesthesiologists (ASA) class I - III (Appendix I).
  3. Female patients of childbearing potential must be using an effective method of birth control at the time of screening visit
  4. Patients who are expected to have moderate-to-severe post-operative pain for at least 24 hours.

Exclusion Criteria (additional criteria not specified here):

  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
  2. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug.
  3. Patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (CPAP).
  4. Patients who previously have had abdominoplasty or have had an inguinal hernia repair on the same side.

Sites / Locations

  • Shoals Medical Trials, Inc
  • Lotus Clinical Research
  • Victory Medical Center
  • Research Concepts, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sufentanil Tablet 30 mcg

Placebo Tablet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Patient Global Assessment
Proportion of patients who responded good or excellent to the global assessment of method of pain control at 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
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.
Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population
Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population

Full Information

First Posted
February 2, 2015
Last Updated
December 21, 2016
Sponsor
AcelRx Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02356588
Brief Title
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AcelRx Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sufentanil Tablet 30 mcg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Tablet
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sufentanil Tablet 30 mcg
Other Intervention Name(s)
ST 30 mcg
Intervention Type
Drug
Intervention Name(s)
Placebo Tablet
Other Intervention Name(s)
PT
Primary Outcome Measure Information:
Title
Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
Description
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.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).
Description
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.
Time Frame
24 hours
Title
TOTPAR12
Description
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.
Time Frame
12 hours
Title
TOTPAR24
Description
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.
Time Frame
24 Hours
Title
Time-weighted SPRID12
Description
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.
Time Frame
12 hours
Title
Time-weighted SPRID24
Description
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.
Time Frame
24 hours
Title
Patient Global Assessment
Description
Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours
Time Frame
24 hours
Title
Healthcare Professional Global Assessment
Description
Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours
Time Frame
24 hours
Title
Summed Pain Intensity Difference
Description
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.
Time Frame
1 hour
Title
Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population
Time Frame
Cumulative through 12 hours
Title
Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population
Time Frame
24 hours
Title
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Time Frame
Cumulative through 6 hours
Title
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Time Frame
Cumulative through 12 hours
Title
Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
Time Frame
Cumulative through 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Palmer, M.D., PhD
Organizational Affiliation
AcelRx Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Shoals Medical Trials, Inc
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Lotus Clinical Research
City
Pasadena
State/Province
California
ZIP/Postal Code
91106
Country
United States
Facility Name
Victory Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Research Concepts, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States

12. IPD Sharing Statement

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

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