This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for postoperative pain management in abdominal surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
HL-1186 tablet for oral administration.
HL-1186 placebo tablet for oral administration.
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGSPID48
SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score).
Time frame: 0 to 48 hours
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day 1 to Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.