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NCT Number: NCT02356588

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

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shoals Medical Trials, Inc, Sheffield, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sufentanil Tablet 30 mcg

Drug

Other names: ST 30 mcg

Placebo Tablet

Drug

Other names: PT

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Talphera, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 5, 2015
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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