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

Primary Purpose

Moderate-to-severe Acute Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sufentanil sublingual 30 mcg tablet
Sponsored by
AcelRx Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate-to-severe Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hennepin County Medical Center
  • Hermann Memorial Medical Center
  • Ben Taub General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sufentanil sublingual tablet 30 mcg

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 15, 2015
Last Updated
September 18, 2017
Sponsor
AcelRx Pharmaceuticals, Inc.
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT02447848
Brief Title
Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AcelRx Pharmaceuticals, Inc.
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-severe Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sufentanil sublingual tablet 30 mcg
Arm Type
Experimental
Arm Description
Patients may be administered one tablet every 60 minutes as needed during the study period
Intervention Type
Drug
Intervention Name(s)
sufentanil sublingual 30 mcg tablet
Primary Outcome Measure Information:
Title
Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1).
Description
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.
Time Frame
One hour
Secondary Outcome Measure Information:
Title
TOTPAR1 (Time-weighted)
Description
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.
Time Frame
1-hour
Title
PI at Each Evaluation Time Point
Description
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.
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela P. Palmer, MD, PhD
Organizational Affiliation
AcelRx Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Hermann Memorial Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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