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| Name | Class |
|---|---|
| China-Japan Friendship Hospital | OTHER |
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This is a phase II, multicenter ,randomized, double-blind, placebo-controlled, dose-finding study designed to evaluate the efficacy and safety of TRD205 tablets in the treatment of chronic postoperative neuralgia
This study used a placebo as a control to explore the efficacy, safety and pharmacokinetic characteristics of multiple administration of TRD205 tablets at different doses forchronic postoperative neuralgia .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200mg treatment group | Experimental | Take TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks |
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| 400mg treatment group | Experimental | Take TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks |
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| 600mg treatment group | Experimental | Take TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks |
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| Placebo | Placebo Comparator | Take placebo orally once a day every morning for 6 consecutive weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TRD205 tablets | Drug | orally ;Take TRD205 1 tablets and Placebo 2 tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the weekly average NRS (numeric pain rating scale,0~10:0 equated to no pain, and 10 equated to the worst pain imaginable )pain score from baseline after 6 weeks of treatment | The Digital Assessment Scale (NRS) is used to evaluate the degree of pain in patients using the 11-point numeric pain rating scale (0-10; 0 equated to no pain, and 10 equated to the worst pain imaginable).The NRS pain score will be was assessed during the single-blind introduction period, the double-blind treatment period, and at the early end of the visit.The baseline of the NRS pain score is defined as the weekly average of the NRS pain score collected during the single-blind introduction period. Before taking the medicine every morning, the subjects retrospectively evaluated the average pain level in the past 24 hours. In addition, 1 hour before each remedial analgesia, the average pain intensity from the previous use of the investigational drug to the use of the remedial medication should be retrospectively assessed.NRS scores were collected at Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, and at the early end of the visit for the calculation of the weekly average score. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Related Adverse Events | Assessment of all AEs, SAEs and TEAEs | 7 weeks |
| Peak Plasma Concentration(Cmax) | Two samples were collected before administration at Visvisit 7( the last administration) and within 1 to 4 hours after administration.The blood drug concentration data of TRD205 obtained in this study will be combined with the previously completed clinical research data for population pharmacokinetic analysis (using the nonlinear mixed-effects model [NONMEM]), and a population pharmacokinetic model will be established to characterize the PK characteristics of TRD205.Then, based on the parameter estimates of the established final population pharmacokinetic model, the individual exposure parameters of the subjects were estimated for further dose-effect (exposing-effect) analysis, including the correlation exploration analysis of PK/ efficacy and PK/ safety. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | China |
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| TRD205 tablets |
| Drug |
orally ;Take TRD205 2 tablets and Placebo 1 tablets |
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| TRD205 tablets | Drug | orally ;Take TRD205 3 tablets and Placebo 0 tablets |
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| Placebo | Drug | orally ;Take Placebo 3 tablets |
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| Within 4 hours after the last administration |
| Area under the plasma concentration versus time curve (AUC) | Two samples were collected before administration at Visvisit 7( the last administration) and within 1 to 4 hours after administration.The blood drug concentration data of TRD205 obtained in this study will be combined with the previously completed clinical research data for population pharmacokinetic analysis (using the nonlinear mixed-effects model [NONMEM]), and a population pharmacokinetic model will be established to characterize the PK characteristics of TRD205.Then, based on the parameter estimates of the established final population pharmacokinetic model, the individual exposure parameters of the subjects were estimated for further dose-effect (exposing-effect) analysis, including the correlation exploration analysis of PK/ efficacy and PK/ safety. | Within 4 hours after the last administration |