A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery

Recruiting Phase 3 Interventional Study
Postoperative Pain Management
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 74
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
405 (estimated)
Sponsor
Haisco Pharmaceutical Group Co., Ltd. · Industry
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About This Trial

This is a multi-center, randomized, double-blind, placebo/active-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 18 years old ≤ age ≤74 years old, regardless of gender; * 18 kg/m2≤BMI≤32 kg/m2,meet the weight range specified in the protocol; * American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ; * Accept hip replacement under general anesthesia; * Within 4 hours after the end of surger…
Contacts

Jianwei Tang

028-67258779

tangjianw@haisco.com

CONTACT