This is a phase II/III, multi-center, randomized, double-blind, comparator-controlled study to evaluate the efficacy and safety of HRS-2129 for postoperative pain management in abdominal surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
360
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGThe Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGThe time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product.
Time frame: Within 48 hours after the start of administration of the investigational product.
The time-weighted sums of differences in resting pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration (Sum of Pain Intensity Difference, SPID).
Time frame: At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
The time-weighted sums of differences in movement-related pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
Time frame: At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.
Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in resting pain Numeric Rating Scales (NRS) scores from baseline at 24 hours and 48 hours after the first dose.
Time frame: At 24 hours and 48 hours after the first dose.
Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in movement-related pain NRS scores from baseline at 24 hours and 48 hours after the first dose.
Time frame: At 24 hours and 48 hours after the first dose.
Percentage of subjects who did not use rescue analgesics within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.
Time frame: Within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.
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