About this trial
This is a phase IIa, multicenter ,randomized, double-blind, placebo-controlled study designed to evaluate the safety, efficacy and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty
Eligibility criteria
Qualifiers
Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent form, and voluntarily comply with the trial procedures;
18 to 80 years of age, male or female;
18 kg/m 2 ≤ BMI ≤ 32 kg/m 2 , Incl. Cutoff ;
American Society of Anesthesiologists (ASA) physical status I to II (Appendix 6);
Disqualifiers
Known allergies or contraindications to the investigational drug and other drugs that may be used during the trial, and those who are not suitable for participating in the trial judged by the investigator;
Use the following drugs within 5 half-lives before randomization (subject to the actual drug instructions, if the half-life is unknown, wash out according to 48h), including but not limited to: analgesic drugs (except specified in the protocol), anticonvulsants, sedative-hypnotic drugs (except used according to the protocol), anxiolytics, antidepressants, CYP3A4 enzyme inhibitors or inducers, etc., use of Chinese herbal medicine with clear analgesic effect assessed by the investigator within 7 days before randomization; sign the ICF to successfully use intra-articular injection of cocktail therapy (specific drugs include but not limited to local anesthetics such as ropivacaine, lidocaine, bupivacaine; analgesics such as morphine; steroid drugs such as dexamethasone and methylprednisolone); refer to the list of prohibited drugs for specific types;
Patients who cannot take oral drugs after surgery as judged by the investigator;
Patients who received ipsilateral hip surgery within 1 year before randomization;
Trial design
Treatments tested in this trial
- TRD205 tablets
- TRD205 tablets
- TRD205 tablets
- placebo
Treatment groups
Sponsors and collaborators
Beijing Tide Pharmaceutical Co., Ltd
Lead sponsor
The Third Affiliated Hospital of Southern Medical University
Collaborator