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

NCT02356588 | Completed Phase 3 Results

• 1 other identifier: SAP301
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 4

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.

Conditions

Post-Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  12 hours

Secondary Outcomes (13)

• Time-weighted Summed Pain Intensity Difference (SPID) Over the 24-hour Study Period (SPID24).

  24 hours

• TOTPAR12

  12 hours

• TOTPAR24

  24 Hours

• Time-weighted SPRID12

  12 hours

• Time-weighted SPRID24

  24 hours

Study Arms (2)

Sufentanil Tablet 30 mcg

EXPERIMENTAL

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

Placebo Tablet

PLACEBO COMPARATOR

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

Interventions

Sufentanil Tablet 30 mcg DRUG

Also known as: ST 30 mcg

Sufentanil Tablet 30 mcg

Placebo Tablet DRUG

Also known as: PT

Placebo Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Talphera, Inc: lead

Study Sites (4)

Shoals Medical Trials, Inc

Sheffield, Alabama, 35660, United States

Location

Lotus Clinical Research

Pasadena, California, 91106, United States

Location

Victory Medical Center

Houston, Texas, 77004, United States

Location

Research Concepts, LLC

Houston, Texas, 77024, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pamela Palmer, MD, PhD
• Organization: AcelRx Pharmaceuticals, Inc.

ppalmer@acelrx.com

650-216-3504

Study Officials

• Pamela Palmer, M.D., PhD

  Talphera, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 5, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 13, 2017
• Results First Posted: February 13, 2017

Record last verified: 2016-12

Locations

US (4)