Clinical trial NCT02356588: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Operative Pain
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).
timeFrame: 12 hours
Secondary outcomes:
measure: Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).
timeFrame: 24 hours
measure: TOTPAR12
timeFrame: 12 hours
measure: TOTPAR24
timeFrame: 24 Hours
measure: Time-weighted SPRID12
timeFrame: 12 hours
measure: Time-weighted SPRID24
timeFrame: 24 hours
measure: Patient Global Assessment
timeFrame: 24 hours
measure: Healthcare Professional Global Assessment
timeFrame: 24 hours
measure: Summed Pain Intensity Difference
timeFrame: 1 hour
measure: Analysis of Total Number of Doses Used During the 12-Hour Study Period in the ITT Population
timeFrame: Cumulative through 12 hours
measure: Analysis of Total Number of Doses Used During the 24-Hour Study Period in the ITT Population
timeFrame: 24 hours
measure: Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
timeFrame: Cumulative through 6 hours
measure: Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
timeFrame: Cumulative through 12 hours
measure: Summary of Number of Rescue Morphine Doses Used by Study Period in the ITT Population
timeFrame: Cumulative through 24 hours
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Shoals Medical Trials, Inc
state: Alabama
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Houston
country: United States
facility: Victory Medical Center
state: Texas
city: Houston
country: United States
facility: Research Concepts, LLC
state: Texas
Study officials:
affiliation: Talphera, Inc
name: Pamela Palmer, M.D., PhD
role: STUDY_DIRECTOR
References: