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

Moderate-to-severe Acute Pain Clinical Trial

Official title:

A Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for the Treatment of Acute Pain in Patients in Emergency Room Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447848
• Other study ID #: SAP302
• Status: Completed
• Phase: Phase 3
• First received: May 15, 2015
• Last updated: September 18, 2017
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2017
• Source: AcelRx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study is a multicenter, open-label trial, in patients 18 years and older, who present to the ER with moderate-to-severe acute pain due to obvious trauma or injury evident on physical examination.

Upon meeting all entrance criteria, patients will be administered up to four doses of sufentanil 30 mcg and remain in the study for 5 hours for safety and efficacy measurements.

Safety will be monitored via periodic measurement of vital signs and continuous monitoring of oxygen saturation, as well as assessment of adverse events (AEs) and the use of concomitant medications.

Efficacy will be assessed by patient reports of pain intensity (PI) and pain relief. A Six-Item Screener (SIS) will be administered before and 1 hour after study drug administration to measure cognitive impairment. The Patient Global Assessment (PGA) and the Healthcare Professional Global Assessment (HPGA) will assess global satisfaction with the method of pain control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Acute Pain
• Moderate-to-severe Acute Pain

Intervention

Drug:
• sufentanil sublingual 30 mcg tablet

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas
United States	Hermann Memorial Medical Center	Houston	Texas
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
AcelRx Pharmaceuticals, Inc.	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TOTPAR1 (Time-weighted)	The total pain relief (TOTPAR) is the time-weighted sum of the pain relief scores over the first hour (15 minutes, 30 minutes, 45 minutes and 1-hour after the first dose of study drug is taken) of the study period.; The minimum score is 0.00 and the maximum score is 4.00. A higher score indicates greater pain relief.	1-hour
Secondary	PI at Each Evaluation Time Point	Pain intensity at each evaluation time point after the first dose of study drug up through 5 hours is evaluated using an 11-point NRS where 0 equals no pain and 10 equals worst possible pain. The score was obtained at Baseline, 15- , 30-, 45- minutes, 1-hour, and 2-hours after the first dose for all patients, and at hours 3, 4, and 5 for cohort 2 (patients 41-76). Scores ranged from 0 -10 for the first two hours, and 2 - 10 for hours three to five.	5 hours