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

Talphera, Inc161 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

161

Conditions

Post-Operative Pain

Interventions

Sufentanil Tablet 30 mcgDRUG

Placebo TabletDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Shoals Medical Trials, Inc

Sheffield, Alabama, United States

Lotus Clinical Research

Pasadena, California, United States

Victory Medical Center

Houston, Texas, United States

Research Concepts, LLC

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 hours

Secondary Outcomes

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.

Time frame: 24 hours

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.

Time frame: 12 hours

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.

Data from ClinicalTrials.gov

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