A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg in Patients With Post-Operative Pain

NCT02662556 | Completed Phase 3 Results

• 1 other identifier: SAP303
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. Patients may receive one dose of ST 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Conditions

Acute Moderate-to-severe Pain

Outcome Measures

Primary Outcomes (1)

• Time-weighted Summed Pain Intensity Difference (SPID) Over the 12-hour Study Period (SPID12).

  The pain intensity difference (PID) at each evaluation time point after the dose of study drug is the difference in pain intensity at the specific evaluation time point and baseline pain intensity \[PID(evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. A pain intensity score ranging from 0 (no pain) to 10 (worst possible pain) is obtained at baseline and throughout the 12 hour period. The time-weighted SPID12 is the time-weighted summed PID over the 12-hour study period. The scores ranged from -13.75 to 100.5. A negative score indicates an increase in pain intensity and a higher score indicates a greater decrease in pain intensity.

  12-hours

Secondary Outcomes (3)

• Time-weighted Summed Pain Intensity Difference (SPID) Over the First Hour (SPID1).

  1 hours

• Percentage of Patients Who Responded to the Global Assessments as "Excellent" or "Good"

  12 hours or at patients' termination from study

• Percentage of Healthcare Professionals Who Responded to the Global Assessments as "Excellent" or "Good"

  12 hours or until patients' termination from study

Study Arms (1)

sufentanil sublingual tablet 30 mcg

EXPERIMENTAL

sufentanil sublingual tablet 30 mcg

Drug: sufentanil sublingual tablet 30 mcg

Interventions

sufentanil sublingual tablet 30 mcg DRUG

sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

Also known as: ST 30 mcg

sufentanil sublingual tablet 30 mcg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients who are 40 years of age or older.
• Patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
• Patients classified as American Society of Anesthesiologists (ASA) class IIII (Appendix I).

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 (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
• Patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication.
• Patients with a history of opioid dependence within 2 years before the start of the study, defined as meeting the DSM-IV-TR™ Criteria for Substance Dependence specified in Appendix II.
• Patients who have used any illicit drugs of abuse within five years before the start of the study.
• Patients who have abused any prescription medication or alcohol within one year before the start of the study.
• Patients with an allergy or hypersensitivity to opioids.
• 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).

Sponsors & Collaborators

• Talphera, Inc: lead

Study Sites (2)

HD Research

Houston, Texas, 77401, United States

Location

Research Concepts

Houston, Texas, 77401, United States

Location

Results Point of Contact

• Title: Pamela P. Palmer, MD, PhD, Chief Medical Officer
• Organization: AcelRx Pharmaceuticals, Inc.

ppalmer@acelrx.com

650-216-3504

Study Officials

• Pamela P. Palmer, MD, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: March 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01

Locations

US (2)