At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 387 enrolled
Drug / intervention
HSK21542 Injection +2 moredrug
Likely dose
HSK21542 Injection 1μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double-Blind, Placebo/Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection for Postoperative Pain Treatment
In Brief
A Phase 3 clinical trial evaluating HSK21542 Injection, Tramadol hydrochloride, and 1 other intervention for Postoperative Analgesia. Completed, enrolled 387 participants across 1 site.
Detailed Summary
This is a multi-center, randomized, double-blind, placebo/active-controlled study. About 387 subjects undergoing elective abdominal operation under general anesthesia are planned to be enrolled and randomized into the HSK21542 group (129 subjects), tramadol group (129 subjects), and placebo group (129 subjects).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Analgesia
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedMay 2022
Enrollment StartJun 2022
Primary CompletionDec 2022
Study CompletionMar 2023
TodayJul 2026
First PostedMay 25, 2022
Enrollment StartJun 8, 2022
Primary CompletionDec 16, 2022
Study CompletionMar 28, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.1 years ago
Interventions
HSK21542 Injectiondrug
1μg/kg/dose
Tramadol hydrochloridedrug
50mg/dose
placebodrug
placebo