To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty
NCT07121101 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-08-13
Summary
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
Conditions
- Postoperative Analgesia After Unilateral Hip Arthroplasty
Interventions
- DRUG
-
TRD205 tablets
Administered orally every 12 hours for a total of four times;Take TRD205 2 tablets and Placebo 4 tablets for the first time ,TRD205 1 tablets and Placebo 2 tablets each for the other three times
- DRUG
-
TRD205 tablets
Administered orally every 12 hours for a total of four times;Take TRD205 4 tablets and Placebo 2 tablets for the first time ,TRD205 2 tablets and Placebo 1 tablets each for the other three times.
- DRUG
-
TRD205 tablets
Administered orally every 12 hours for a total of four times;Take TRD205 6 tablets and Placebo 0 tablets for the first time ,TRD205 3 tablets and Placebo 0 tablets each for the other three times.
- DRUG
-
Administered orally every 12 hours for a total of four times;Take Placebo 6 tablets for the first time ,Placebo 3 tablets each for the other three times.
Sponsors & Collaborators
-
The Third Affiliated Hospital of Southern Medical University
collaborator OTHER_GOV -
Beijing Tide Pharmaceutical Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-26
- Primary Completion
- 2025-11-20
- Completion
- 2025-12-27
Countries
- China
Study Locations
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