Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain

NCT02447848 | Completed Phase 3 Results

• 1 other identifier: SAP302
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate the safety and efficacy of sufentanil tablet (ST) 30 mcg in the management of moderate-to-severe acute pain in patients in an emergency room (ER) setting.

Conditions

Moderate-to-severe Acute Pain

Outcome Measures

Primary Outcomes (1)

• Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).

  The primary efficacy endpoint is the time-weighted SPID1 evaluated from the patient questionnaire data. Pain intensity (PI) will be measured using an 11-point numerical rating scale (NRS) with 0 (no pain) and 10 (worst possible pain). The patient's rating of PI will be measured at baseline and at 0.25 (15 min), 0.5 (30 min), 0.75 (45 min), 1, 2, 3, 4, and 5 hours following the first dose of study drug. The PID at each evaluation time point after the initiation of the first dose is the difference in PI at the specific evaluation time point and baseline pain intensity \[PID (evaluation time after the first dose) = PI(baseline) - PI(evaluation time after the first dose)\]. The time-weighted SPID1 is the time-weighted summed PID over the 1-hour study period. The observed SPID scores ranged from -.70 to 8.00. A negative score indicates an increase in pain intensity and a positive score indicates a decrease in pain intensity.

  One hour

Secondary Outcomes (2)

• TOTPAR1 (Time-weighted)

  1-hour

• PI at Each Evaluation Time Point

  5 hours

Study Arms (1)

sufentanil sublingual tablet 30 mcg

EXPERIMENTAL

Patients may be administered one tablet every 60 minutes as needed during the study period

Drug: sufentanil sublingual 30 mcg tablet

Interventions

sufentanil sublingual 30 mcg tablet DRUG

sufentanil sublingual tablet 30 mcg

Eligibility Criteria

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

You may qualify if:

• Patients who present to the ER with moderate-to-severe pain due to obvious trauma or injury evident on physical examination.
• Patients classified as American Society of Anesthesiologists (ASA) class I-III
• Patients who are willing and capable of understanding and cooperating with the requirements of the study.
• Patients able to understand and communicate in English.
• Patients who have provided written informed consent and signed the IRB approved consent form.

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 (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
• Patients who have used any illicit drugs of abuse, abused prescription medication or alcohol (4 or more drinks per day) 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 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).
• Female patients who are pregnant (positive pregnancy test) or breastfeeding.
• Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.
• Patients who present to the ER using supplemental oxygen.
• Patients who have participated in a clinical trial of an investigational drug or device within 30 days of enrollment.
• Patients who are active or reserve duty with the US military.

Sponsors & Collaborators

• Talphera, Inc: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (3)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Hermann Memorial Medical Center

Houston, Texas, 77024, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Pamela Palmer, MD, PhD
• 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: May 15, 2015
• First Posted: May 19, 2015
• Study Start: October 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 19, 2017
• Results First Posted: October 19, 2017

Record last verified: 2017-07

Locations

US (3)