Diabetic Peripheral Neuropathic PainNCT06546202
Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China
An observational study of Diabetic Peripheral Neuropathic Pain and Chemotherapy-induced Peripheral Neuropathy, run by Daiichi Sankyo at 10 sites in China.
Trial summary
The aim of this study is to investigate the pharmacological treatment pattern among patients with diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain
- What is being tested?
- No Drug
- How many people
- 1,271 participants
- Where
- 10 sitesChina
- Study dates
- 16 Aug 2024to 18 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study target population is eligible participants from general hospitals and oncology-specialized hospitals in several provinces and regions of China who were diagnosed with DPNP or CIPN between 1st January 2018 and 31st December 2021 and received the targeted medications.
Participants who meet all the following criteria will be included in the DPNP cohort.
- Participants were diagnosed with diabetic neuropathy and presented with the pain symptom between 1st January 2018 and 31st December 2021;
- Participants received at least one targeted medication between 1st January 2018 and 31st December 2021;
- Participants were ≥18 years on the index date;
- Participants had at least one medical visit record within 12 months after the index date
Participants who meet any one of the following criteria will be excluded from the DPNP cohort.
(1) Participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date
Participants who meet all the following criteria will be included in the CIPN cohort.
- Participants had neuropathy that was induced by the chemotherapy between 1st January 2018 and 31st December 2021, regardless of the presence of pain symptoms;
- Participants received at least one targeted medication between 1st January 2018 and 31st December 2021;
- Participants were ≥18 years on the index date;
- Participants had at least one medical visit record within12 months after the index date
Participants who meet any one of the following criteria will be excluded from the CIPN cohort.
- Participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date;
- Participants had neuralgia or neuropathy caused by tumor metastasis or non-chemotherapy-induced factors (e.g., radiotherapy, myasthenia gravis syndrome, paraneoplastic syndrome, direct tumor invasion, local tissue compression, postoperative traumatic pain, immune therapy-related pain, comorbidity-induced pain, etc.)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
China-Japan Friendship Hospital
Beijing, 100013
Beijing Hospital
Beijing, 100051
Beijing Cancer Hospital
Beijing, 100142
The First Affiliated Hospital of Dalian Medical University
Dalian, 116011
The First Affiliated Hospital of Fujian Medical University
Fuzhou, 350001
Sun Yat-Sen University Cancer Center
Guangzhou, 510060
Zhejiang Provincial People's Hospital
Hangzhou, 314408
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan, 250117
Liaoning Cancer Hospital & Institute
Shenyang, 110000
Tongji Hospital Tongji Medical College of Hust
Wuhan, 430030
About this study
Official title: Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multi-center Study (ReTARdant)
The aim of this study is to investigate the pharmacological treatment pattern among patients with diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) in China.
Read the detailed description
Diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) are common subtypes of neuropathic pain. The treatment pattern, subsequent medication usage, and adherence information of medication among these patients are still not clear. There is also an unmet need for the use of relevant analgesic medications in this area. This real-world data study aims to understand patients' characteristics, clinical diagnosis and treatment patterns, medication adherence, real-world effectiveness among DPNP and CIPN patients in China and will explore the current unmet needs of DPNP and CIPN, in order to inform physicians' decision-making in clinical practice
- Conditions
- Diabetic Peripheral Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain
- Being tested
- No Drug
- Keywords
- Diabetic peripheral neuropathic pain, Chemotherapy-induced peripheral neuropathy, Neuropathic pain, Treatment pattern
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No DrugOther
This is an non-interventional, observational study. No drug was administered during this study.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic peripheral neuropathic pain | Participants who have been diagnosed with diabetic peripheral neuropathic pain and presented with pain symptoms. Receives: Other: No Drug | |
| Chemotherapy-induced peripheral neuropathy | Participants who have chemotherapy-induced peripheral neuropathy regardless of the presence of pain symptoms. Receives: Other: No Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants receiving different treatment regimens (targeted medications or combinations) and related medication categories in participants with DPNP or CIPN
The treatment regimen will be evaluated and confirmed as monotherapy or combination therapy based on prescription records at each visit. Monotherapy is defined as participants only received one targeted medication. Combination therapy is defined as participants received more than one targeted medication at the same time.
Measured: From index date up to 31st December 2022
Proportion of participants who discontinue/switch/add-on treatment and related medication categories in participants with DPNP or CIPN
Treatment discontinuation is defined as the time interval between two adjacent treatment regimens, or the time interval between the end of the last treatment regimen and the study end date (31st December 2022), or the time interval between the end of the last treatment regimen and the date of death is ≥90 days. Treatment switch is defined as the change of treatment regimen, either in monotherapy or in combination (exclude treatment add-on). Treatment add-on is defined as the addition of one or more targeted medications to an existing treatment regimen (monotherapy or combination therapy).
Measured: From index date up to 31st December 2022
Proportion of participants who restarted treatment after discontinuation in participants with DPNP or CIPN
Among those who had discontinued treatment, the proportion of patients who received at least one targeted medication at the next visit will be assessed, where the treatment regimen containing the targeted medication includes the same treatment medication prior to discontinuation or a different treatment medication after treatment switch/add-on.
Measured: From index date up to 31st December 2022
Duration of the current treatment in participants with DPNP or CIPN
Duration of the current treatment is defined as the time interval from the start date of a treatment to its end date. The end date of the treatment refers to its discontinuation date; for participants who did not experience a treatment discontinuation, the end date of treatment prescription is used.
Measured: From index date up to 31st December 2022
Time to treatment add-on in participants with DPNP or CIPN
Time to treatment add-on is defined as the time interval between the end date of the current treatment regimen (including days covered by take-away medications) and the start date of the add-on treatment.
Measured: From index date up to 31st December 2022
Secondary outcomes (4)
Initial daily dose in participants with DPNP or CIPN
Initial daily dose is defined as the first prescribed daily dose of the targeted medications.
Measured: From index date up to 31st December 2022
Maximum daily dose in participants with DPNP or CIPN
Maximum daily dose is defined as the maximum of the daily dose.
Measured: From index date up to 31st December 2022
Time to the maximum daily dose in participants with DPNP or CIPN
Time to the maximum daily dose is defined as the time interval between the daily dose to the maximum daily dose.
Measured: From index date up to 31st December 2022
Proportion of participants who underwent the daily dose change in participants with DPNP or CIPN
Proportion of participants who underwent the daily dose change is defined as the proportion of participants who underwent the dose changes from the initial daily dose to 2 weeks, 4 weeks and 6 weeks, respectively.
Measured: From index date up to 31st December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start16 Aug 2024
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546202
- Sponsor's protocol ID
- DS5565-0001-NIS-MA
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pan Q, Zhai X, Wang H, Du J, Shi Y, Yu X, Yan S, Wu X, Li HH, Sun T, Guo L, Zhao J, Fan B. Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multicenter Study (ReTARdant) Protocol. Pain Ther. 2025 Oct;14(5):1611-1627. doi: 10.1007/s40122-025-00767-x. Epub 2025 Aug 11.
PubMed 40788612
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multi-center Study (ReTARdant)
- ClinicalTrials.gov ID
- NCT06546202
- Acronym / sponsor ID
- DS5565-0001-NIS-MA
- Conditions
- Diabetic Peripheral Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy, Neuropathic Pain
- Keywords
- Diabetic peripheral neuropathic pain, Chemotherapy-induced peripheral neuropathy, Neuropathic pain, Treatment pattern
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,271 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo Co., Ltd.
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 9 Aug 2024 (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.
The aim of this study is to investigate the pharmacological treatment pattern among patients with diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) in China.
Detailed description
Diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) are common subtypes of neuropathic pain. The treatment pattern, subsequent medication usage, and adherence information of medication among these patients are still not clear. There is also an unmet need for the use of relevant analgesic medications in this area. This real-world data study aims to understand patients' characteristics, clinical diagnosis and treatment patterns, medication adherence, real-world effectiveness among DPNP and CIPN patients in China and will explore the current unmet needs of DPNP and CIPN, in order to inform physicians' decision-making in clinical practice
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic peripheral neuropathic pain | – | Other: No DrugParticipants who have been diagnosed with diabetic peripheral neuropathic pain and presented with pain symptoms. |
| Chemotherapy-induced peripheral neuropathy | – | Other: No DrugParticipants who have chemotherapy-induced peripheral neuropathy regardless of the presence of pain symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study target population is eligible participants from general hospitals and oncology-specialized hospitals in several provinces and regions of China who were diagnosed with DPNP or CIPN between 1st January 2018 and 31st December 2021 and received the targeted medications.
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 |
|---|---|---|
| No DrugThis is an non-interventional, observational study. No drug was administered during this study. | Other | Chemotherapy-induced peripheral neuropathy, Diabetic peripheral neuropathic pain |
Primary outcome
Proportion of participants receiving different treatment regimens (targeted medications or combinations) and related medication categories in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
The treatment regimen will be evaluated and confirmed as monotherapy or combination therapy based on prescription records at each visit. Monotherapy is defined as participants only received one targeted medication. Combination therapy is defined as participants received more than one targeted medication at the same time.
Proportion of participants who discontinue/switch/add-on treatment and related medication categories in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
Treatment discontinuation is defined as the time interval between two adjacent treatment regimens, or the time interval between the end of the last treatment regimen and the study end date (31st December 2022), or the time interval between the end of the last treatment regimen and the date of death is ≥90 days. Treatment switch is defined as the change of treatment regimen, either in monotherapy or in combination (exclude treatment add-on). Treatment add-on is defined as the addition of one or more targeted medications to an existing treatment regimen (monotherapy or combination therapy).
Proportion of participants who restarted treatment after discontinuation in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
Among those who had discontinued treatment, the proportion of patients who received at least one targeted medication at the next visit will be assessed, where the treatment regimen containing the targeted medication includes the same treatment medication prior to discontinuation or a different treatment medication after treatment switch/add-on.
Duration of the current treatment in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
Duration of the current treatment is defined as the time interval from the start date of a treatment to its end date. The end date of the treatment refers to its discontinuation date; for participants who did not experience a treatment discontinuation, the end date of treatment prescription is used.
Time to treatment add-on in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
Time to treatment add-on is defined as the time interval between the end date of the current treatment regimen (including days covered by take-away medications) and the start date of the add-on treatment.
4 secondary outcomes
Initial daily dose in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
Maximum daily dose in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
Time to the maximum daily dose in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
Proportion of participants who underwent the daily dose change in participants with DPNP or CIPN
Time frame: From index date up to 31st December 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Derived from this study: PubMed 40788612Pan Q, Zhai X, Wang H, Du J, Shi Y, Yu X, Yan S, Wu X, Li HH, Sun T, Guo L, Zhao J, Fan B. Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multicenter Study (ReTARdant) Protocol. Pain Ther. 2025 Oct;14(5):1611-1627. doi: 10.1007/s40122-025-00767-x. Epub 2025 Aug 11.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Peripheral Neuropathic Pain and Chemotherapy-induced Peripheral Neuropathy, run by Daiichi Sankyo at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants receiving different treatment regimens (targeted medications or combinations) and related medication categories in participants with DPNP or CIPN (time frame: From index date up to 31st December 2022). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546202, which also lists 1 linked publication.
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 23 Jul 2025.