This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
330
HL-1186 tablet for oral administration.
HL-1186 placebo tablet for oral administration.
Oxycodone-Acetaminophen for oral adminstration.
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 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
Time frame: 0-9 days
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Oxycodone-Acetaminophen Matching Placebo for oral adminstration.