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
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02662764 -
Study to Evaluate the Overall Performance of the Zalviso Systemâ„¢ (Sufentanil Sublingual Tablet System) 15 mcg
|
Phase 3 |