To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
486
Unnamed facility
Tbilisi, Georgia
Unnamed facility
Tbilisi, Georgia
Unnamed facility
Bialystok, Poland
Unnamed facility
Gdansk, Poland
To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.
Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.
Time frame: at 60 minutes post dose and at 24 hours
To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events
Time frame: 5-7 days post initial dosing
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30 mg IV once per day
IV placebo once per day
morphine 10-15 mg IV once per day
60 mg IV once per day
Unnamed facility
Lodz, Poland
Unnamed facility
Lublin, Poland
Unnamed facility
Poznan, Poland
Unnamed facility
Ruda Śląska, Poland
Unnamed facility
Szczecin, Poland
Unnamed facility
Belgrade, Serbia
...and 2 more locations