Open-Label Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Acute Pain
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|ClinicalTrials.gov Identifier: NCT02447848|
Recruitment Status : Completed
First Posted : May 19, 2015
Results First Posted : October 19, 2017
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Moderate-to-severe Acute Pain||Drug: sufentanil sublingual 30 mcg tablet||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||October 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||July 2016|
Experimental: sufentanil sublingual tablet 30 mcg
Patients may be administered one tablet every 60 minutes as needed during the study period
Drug: sufentanil sublingual 30 mcg tablet
- Time-weighted Summed Pain Intensity Difference (SPID) Over the 1-hour (SPID1). [ Time Frame: One hour ]
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.
- TOTPAR1 (Time-weighted) [ Time Frame: 1-hour ]
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 [ Time Frame: 5 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447848
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|United States, Texas|
|Hermann Memorial Medical Center|
|Houston, Texas, United States, 77024|
|Ben Taub General Hospital|
|Houston, Texas, United States, 77030|
|Study Director:||Pamela P. Palmer, MD, PhD||AcelRx Pharmaceuticals, Inc.|