Chronic Postoperative NeuralgiaPhase 2TRD205NCT07123402
To Evaluate the Efficacy and Safety of TRD205 Tablets in the Treatment of Chronic Postoperative Neuralgia
A Phase 2 study testing TRD205 tablets in people with Chronic Postoperative Neuralgia, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Postoperative Neuralgia
- What is being tested?
- TRD205 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2025to 27 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years ≤ Age ≤ 80 years (calculated as time of signing ICF), both male and female.
- Subject experienced pain following surgical procedures including Thyroid gland and Breast surgery, orthopedic surgery , thoracotomy Etc. (except neurosurgery, amputation, cesarean section).
- Chronic pain ≥ 3 months post-op with pain localized to the operative site, Or The area of innervation that projects to the nerve at this site (Including radicular pain radiating to one side or limb after spinal surgery) Or involving the dermatome.
- DN4 scale ≥ 4, AND The subject's pain was judged by the investigator to be neuropathic in nature.
- Subjects had moderate to severe pain intensity (ie, averaged over the single-blind run-in period NRS Score ≥ 4 Points, see requirements for single-blind run-in period and randomization criteria for details).
- The subject is able to communicate well with the investigators, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the informed consent form .
- Subject is willing to voluntarily use the contraception specified in the protocol from signing the ICF to 1 month after the last dose of investigational drug (For details see Fig. 附录4) . Both male and female subjects had no plans to donate sperm or ova during the study and for 1 month after investigational product administration.
Who cannot join
- Investigator Judge the pain of subjects in whole or in part Pathological pain or pain in the central nervous system Caused by other postoperative complications (e.g., infection, disease recurrence, etc.).
- Present Other Causally induced pain, such as the presence of skin disease in the affected skin area, cervical and lumbar spine disease, trauma, etc., thus affecting the investigator's evaluation of CPSNP or confusing the subject's self-assessment of CPSNP.
- Presence of other neurological or psychiatric disorders that, in the judgment of the investigator, could confound the subject's self-assessment of CPSNP or affect the subject's ability to complete diary card completion.
- Known history of hypersensitivity to investigational products or components or excipients of rescue medication during the study period, or history of hypersensitivity to two or more drugs.
- Previously Received Any prohibited medication or non-drug therapy, and in Fig. Single-Blind Run-in Period Pre Did not undergo the protocol-required washout period (excluded medications Elution Phase: Single-Blind Run-in Period ≥ 5 half-lives or 7 days prior, whichever is longer; non-drug therapy is prohibited Elution Phase: Single-Blind Run-in Period ≥ 30 days prior) that may interfere with the evaluation of the test drug during the study.
- Have an electrical stimulation instrument or intrathecal drug infusion system implanted to treat pain.
Show all 18Show fewer
- History of alcoholism (> 14 units/week of alcohol, 1 unit is equivalent to 360 mL of beer, or 45 mL of spirits with 40% alcohol, or 150 mL of wine) or drug abuse or drug abuse within 1 year prior to signing the ICF.
- Patients with clinically significant acute or chronic diseases or unstable diseases, such as but not limited to acute cardiovascular disease, cerebrovascular disease, liver, kidney, respiratory system, blood system, immune system and other diseases, inflammatory or rheumatic diseases, uncontrolled infection, untreated endocrine diseases, etc., and affecting the subjects at the investigator's discretion.
- Present Dysphagia Or any gastrointestinal disorder affecting drug absorption.
- Malignancy diagnosed within 2 years prior to signing the ICF (with the exception of non-metastatic cutaneous basal cell or squamous cell carcinoma or carcinoma in situ of the cervix that has been appropriately treated or excised).
- Patients with previous suicidal behavior or a positive response to Item 4 or 5 on the C-SSRS scale (for the 12 months prior to signing the ICF) .
- Systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg; Systolic pressure ≤ 90 mmHg and/or diastolic pressure ≤ 60 mmHg; Heart rate < 50 or > 110 beats per minute.
- Neutrophil count < 1.5 × 10 9 /L; platelet count < 100 × 10 9 /L; Aspartate aminotransferase (AST) > 2.0 × upper limit of normal (ULN); alanine aminotransferase (ALT) > 2.0 × ULN; Urea or urea nitrogen (Urea or BUN) > 1.5 × ULN; Creatine kinase > 2.0 × ULN; Estimated serum creatinine clearance < 60 mL/min by Cockcroft-Gault formula.
- Treponema pallidum antibody or human immunodeficiency virus antibody positive in any test at screening and judged by the investigator as not suitable for the subject .
- Subjects who are expected to require reoperation from signing the ICF to the end of the study.
- Females who are lactating or pregnant, or intend to become pregnant (female subjects or partners of male subjects) during the study period and within 1 month after dosing.
- Those who have participated in or are participating in other clinical trials within 1 month prior to signing the ICF.
- Other conditions not suitable for inclusion as judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Phase II Clinical Trial to Evaluate the Efficacy and Safety of TRD205 Tablets in the Treatment of Chronic Postoperative Neuralgia
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
Read the detailed description
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 .
- Conditions
- Chronic Postoperative Neuralgia
- Being tested
- TRD205 tablets, Placebo
- Keywords
- chronic postoperative neuralgia, TRD205
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRD205 tabletsDrug
orally ;Take TRD205 1 tablets and Placebo 2 tablets
TRD205 tabletsDrug
orally ;Take TRD205 2 tablets and Placebo 1 tablets
TRD205 tabletsDrug
orally ;Take TRD205 3 tablets and Placebo 0 tablets
PlaceboDrug
orally ;Take Placebo 3 tablets
| Study group | Role | What they receive |
|---|---|---|
| 200mg treatment group | Experimental | Take TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks Receives: Drug: TRD205 tablets |
| 400mg treatment group | Experimental | Take TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks Receives: Drug: TRD205 tablets |
| 600mg treatment group | Experimental | Take TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks Receives: Drug: TRD205 tablets |
| Placebo | Placebo comparator | Take placebo orally once a day every morning for 6 consecutive weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (3)
Treatment-Related Adverse Events
Assessment of all AEs, SAEs and TEAEs
Measured: 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.
Measured: 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.
Measured: Within 4 hours after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start9 Apr 2025
- Primary completion20 Apr 2026 (estimated)
- Study completion27 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123402
- Sponsor's protocol ID
- TRD205-II-01
- Acronym
- TRD205
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Phase II Clinical Trial to Evaluate the Efficacy and Safety of TRD205 Tablets in the Treatment of Chronic Postoperative Neuralgia
- ClinicalTrials.gov ID
- NCT07123402
- Acronym / sponsor ID
- TRD205 / TRD205-II-01
- Conditions
- Chronic Postoperative Neuralgia
- Keywords
- chronic postoperative neuralgia, TRD205
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- China-Japan Friendship Hospital
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 20 Apr 2026 (estimated)
- Study completion
- 27 May 2026 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200mg treatment group | Experimental | Drug: TRD205 tabletsTake TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks |
| 400mg treatment group | Experimental | Drug: TRD205 tabletsTake TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks |
| 600mg treatment group | Experimental | Drug: TRD205 tabletsTake TRD205 tables or placebo orally once a day every morning for 6 consecutive weeks |
| Placebo | Placebo comparator | Drug: PlaceboTake placebo orally once a day every morning for 6 consecutive weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 Years ≤ Age ≤ 80 years (calculated as time of signing ICF), both male and female.
- Subject experienced pain following surgical procedures including Thyroid gland and Breast surgery, orthopedic surgery , thoracotomy Etc. (except neurosurgery, amputation, cesarean section).
- Chronic pain ≥ 3 months post-op with pain localized to the operative site, Or The area of innervation that projects to the nerve at this site (Including radicular pain radiating to one side or limb after spinal surgery) Or involving the dermatome.
- DN4 scale ≥ 4, AND The subject's pain was judged by the investigator to be neuropathic in nature.
- Subjects had moderate to severe pain intensity (ie, averaged over the single-blind run-in period NRS Score ≥ 4 Points, see requirements for single-blind run-in period and randomization criteria for details).
Key exclusion criteria (18 listed)
- Investigator Judge the pain of subjects in whole or in part Pathological pain or pain in the central nervous system Caused by other postoperative complications (e.g., infection, disease recurrence, etc.).
- Present Other Causally induced pain, such as the presence of skin disease in the affected skin area, cervical and lumbar spine disease, trauma, etc., thus affecting the investigator's evaluation of CPSNP or confusing the subject's self-assessment of CPSNP.
- Presence of other neurological or psychiatric disorders that, in the judgment of the investigator, could confound the subject's self-assessment of CPSNP or affect the subject's ability to complete diary card completion.
- Known history of hypersensitivity to investigational products or components or excipients of rescue medication during the study period, or history of hypersensitivity to two or more drugs.
- Previously Received Any prohibited medication or non-drug therapy, and in Fig. Single-Blind Run-in Period Pre Did not undergo the protocol-required washout period (excluded medications Elution Phase: Single-Blind Run-in Period ≥ 5 half-lives or 7 days prior, whichever is longer; non-drug therapy is prohibited Elution Phase: Single-Blind Run-in Period ≥ 30 days prior) that may interfere with the evaluation of the test drug during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRD205 tabletsorally ;Take TRD205 1 tablets and Placebo 2 tablets | Drug | 200mg treatment group |
| TRD205 tabletsorally ;Take TRD205 2 tablets and Placebo 1 tablets | Drug | 400mg treatment group |
| TRD205 tabletsorally ;Take TRD205 3 tablets and Placebo 0 tablets | Drug | 600mg treatment group |
| Placeboorally ;Take Placebo 3 tablets | Drug | Placebo |
Primary outcome
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
Time frame: 8 weeks
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.
3 secondary outcomes
Treatment-Related Adverse Events
Time frame: 7 weeks
Peak Plasma Concentration（Cmax）
Time frame: Within 4 hours after the last administration
Area under the plasma concentration versus time curve （AUC）
Time frame: Within 4 hours after the last administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRD205 tablets in people with Chronic Postoperative Neuralgia, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.