Efficacy and Safety of TRD205 Tablets for Postoperative Analgesia in Unilateral Total Hip Arthroplasty (Phase IIb)

ConditionPostoperative Analgesia After Unilateral Hip Arthroplasty

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorBeijing Tide Pharmaceutical Co., Ltd

About this trial

This is a phase IIa, multicenter ,randomized, double-blind, Double-Dummy, Active- and placebo-controlled study designed to evaluate the efficacy, safety and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty

Eligibility criteria

Qualifiers

Able to provide written informed consent

Age 18 to 80 years, inclusive

BMI 18-32 kg/m²

ASA physical status I-II

Disqualifiers

Hypersensitivity to TRD205, celecoxib, or study-related medications

Use of prohibited analgesics, sedatives, CYP3A4 inhibitors/inducers, or analgesic herbs within specified washout periods

Inability to take oral medications postoperatively

Ipsilateral hip surgery within 1 year; contralateral hip surgery within 1 month

Trial design

Treatments tested in this trial

TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses
TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses
TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses
Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses
Matching placebo tablets and capsules, same dosing schedule

Treatment groups

200 Participants

are divided into 5 treatment groups

Sponsors and collaborators

Beijing Tide Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov