Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02356588
Recruitment Status : Completed
First Posted : February 5, 2015
Results First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Post-Operative Pain Drug: Sufentanil Tablet 30 mcg Drug: Placebo Tablet Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sufentanil Tablet 30 mcg
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.
Drug: Sufentanil Tablet 30 mcg
Other Name: ST 30 mcg

Placebo Comparator: Placebo Tablet
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.
Drug: Placebo Tablet
Other Name: PT




Primary Outcome Measures :
  1. Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12). [ Time Frame: 12 hours ]

    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 :
  1. Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24). [ Time Frame: 24 hours ]
    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.

  2. TOTPAR12 [ Time Frame: 12 hours ]
    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.

  3. TOTPAR24 [ Time Frame: 24 Hours ]
    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.

  4. Time-weighted SPRID12 [ Time Frame: 12 hours ]
    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.

  5. Time-weighted SPRID24 [ Time Frame: 24 hours ]
    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.

  6. Patient Global Assessment [ Time Frame: 24 hours ]
    Proportion of patients who responded good or excellent to the global assessment of method of pain control at 24 hours

  7. Healthcare Professional Global Assessment [ Time Frame: 24 hours ]
    Proportion of Health Care Professionals who responded good or excellent to the global assessment of method of pain control at 24 hours

  8. Summed Pain Intensity Difference [ Time Frame: 1 hour ]

    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.


  9. Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population [ Time Frame: Cumulative through 12 hours ]
  10. Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population [ Time Frame: 24 hours ]
  11. Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population [ Time Frame: Cumulative through 6 hours ]
  12. Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population [ Time Frame: Cumulative through 12 hours ]
  13. Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population [ Time Frame: Cumulative through 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356588


Locations
Layout table for location information
United States, Alabama
Shoals Medical Trials, Inc
Sheffield, Alabama, United States, 35660
United States, California
Lotus Clinical Research
Pasadena, California, United States, 91106
United States, Texas
Victory Medical Center
Houston, Texas, United States, 77004
Research Concepts, LLC
Houston, Texas, United States, 77024
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Pamela Palmer, M.D., PhD AcelRx Pharmaceuticals, Inc.
Layout table for additonal information
Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02356588    
Other Study ID Numbers: SAP301
First Posted: February 5, 2015    Key Record Dates
Results First Posted: February 13, 2017
Last Update Posted: February 13, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics