Postoperative Analgesia After Unilateral Hip Arthroplasty
Conditions
Brief summary
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
Detailed description
This study used Active and placebo as a control to explore the efficacy, safety and pharmacokinetic characteristics of multiple administration of different doses of TRD205 tablets for postoperative analgesia after unilateral total hip replacement surgery
Interventions
DRUGTRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses
First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
DRUGTRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses
First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
DRUGTRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses
First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
DRUGCelecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses
First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
DRUGMatching placebo tablets and capsules, same dosing schedule
First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)
Sponsors
Beijing Tide Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Able to provide written informed consent * Age 18 to 80 years, inclusive * BMI 18-32 kg/m² * ASA physical status I-II * Scheduled for elective unilateral total hip arthroplasty under general anesthesia * Able to understand study procedures and pain rating scales
Exclusion criteria
* 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 * Hip revision surgery, developmental dysplasia Crowe type IV, or tumor involving hip * Clinically significant hemodynamic instability or cardiac arrhythmia * Severe hepatic, renal, cardiovascular, or metabolic disease * History of NSAID-induced asthma, active peptic ulcer disease * Drug or alcohol abuse within 1 year * Pregnancy, breastfeeding, or lack of effective contraception * Participation in another interventional clinical trial within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery | 0 to 48 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of resting pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively | 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively | — |
| AUC of movement pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively | 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively | — |
| Cumulative morphine-equivalent rescue analgesic dose at 0-4, 0-6, 0-12, 0-24, 0-48 hours | 0-4, 0-6, 0-12, 0-24, 0-48 hours after surgery | — |
| Time to first rescue analgesia | Within 48 hours after the surgery, the period from the end of the surgery to the first administration of analgesic medication for relief purposes | — |
| Number and proportion of participants using rescue analgesia | 0-48 hours postoperatively | — |
| Participant and investigator satisfaction with analgesia with the 5-point scale,the score range from 0 to 4, where 0 indicates poor, 1 indicates average, 2 indicates good, 3 indicates very good, and 4 indicates excellent. | 48 hours postoperatively | At 48 hours after the surgery, the participants and the research doctors respectively evaluated the overall pain relief satisfaction of the test drug used on a 5-point scale, with the score range from 0 to 4, where 0 indicates poor, 1 indicates average, 2 indicates good, 3 indicates very good, and 4 indicates excellent. |
| By evaluating security metrics such as AEs, SAEs and TEAEs to evaluate the safety of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty. | 5 days | — |
Countries
China
Contacts
CONTACTxiaohong zhang Beijing Tide Pharmaceutical Co., Ltd
Outcome results
None listed