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To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hip Arthroplasty

ConditionPostoperative Analgesia After Unilateral Hip Arthroplasty
Trial statusNot yet recruiting
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, placebo-controlled study designed to evaluate the safety, efficacy and kinetic characteristics of TRD205 tablets for postoperative analgesia after unilateral hip arthroplasty

Eligibility criteria

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • TRD205 tablets

    Drug

    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

  • TRD205 tablets

    Drug

    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.

  • TRD205 tablets

    Drug

    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.

  • placebo

    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.

Treatment groups

40 Participants
are divided into 4 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: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment-Related Adverse Events

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.

Time frame
5 days
2

The total dose of morphine was administered to the patient 0 to 48 hours after the operation

To evaluate the efficacy of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty

Time frame
Within 48 hours after the first administration

Secondary outcomes

1

Peak Plasma Concentration（Cmax）

To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty

Time frame
From 1 hour before the first administration to 48 hours after the last administration.
2

Minimum concentration （Cmin)

To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty

Time frame
From 1 hour before the first administration to 48 hours after the last administration
3

Time to peak（Tmax）

To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty

Time frame
From 1 hour before the first administration to 48 hours after the last administration
4

elimination half life（T1/2）

To evaluate the pharmacokinetic (PK) of multiple administration of TRD205 tablets in patients with postoperative analgesia after unilateral hip arthroplasty

Time frame
From 1 hour before the first administration to 48 hours after the last administration

Other outcomes

Sponsors and contacts

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

Beijing Tide Pharmaceutical Co., Ltd

Lead sponsor

The Third Affiliated Hospital of Southern Medical University

Collaborator

Source ClinicalTrials.gov

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