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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • TRD205 Tablets, oral; 400 mg initial dose, then 200 mg q12h for 3 doses; total 4 doses

    Drug

    First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

  • TRD205 Tablets, oral; 800 mg initial dose, then 400 mg q12h; total 4 doses

    Drug

    First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

  • TRD205 Tablets, oral; 1200 mg initial dose, then 600 mg q12h; total 4 doses

    Drug

    First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

  • Celecoxib, oral; 400 mg initial dose, then 200 mg q12h; total 4 doses

    Drug

    First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

  • Matching placebo tablets and capsules, same dosing schedule

    Drug

    First dose 2-4 hours before anesthesia induction; subsequent doses q12h (±4 hours window if nighttime)

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: 200mg treatment groupExperimental treatment 1 intervention
Group B: 400mg treatment groupExperimental treatment 1 intervention
Group C: 600mg treatment groupExperimental treatment 1 intervention
Group D: Active Control (Celecoxib)Active comparator 1 intervention
Group E: Placebo ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Area under the pain intensity-time curve (AUC0-48h) of resting pain NRS from 0 to 48 hours after surgery

Time frame
0 to 48 hours after surgery

Secondary outcomes

1

AUC of resting pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively

Time frame
0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively
2

AUC of movement pain NRS at 0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively

Time frame
0-4, 0-6, 0-12, 0-24, 24-48 hours postoperatively
3

Cumulative morphine-equivalent rescue analgesic dose at 0-4, 0-6, 0-12, 0-24, 0-48 hours

Time frame
0-4, 0-6, 0-12, 0-24, 0-48 hours after surgery
4

Time to first rescue analgesia

Time frame
Within 48 hours after the surgery, the period from the end of the surgery to the first administration of analgesic medication for relief purposes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tide Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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