Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China

NCT06546202 | Completed

• 1 other identifier: DS5565-0001-NIS-MA
• Study Type: observational
• Target: 1,271
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Diabetic Peripheral Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy; Neuropathic Pain

Keywords

Diabetic peripheral neuropathic pain; Chemotherapy-induced peripheral neuropathy; Neuropathic pain; Treatment pattern

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

  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.

  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.

  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.

  From index date up to 31st December 2022

Secondary Outcomes (4)

• Initial daily dose in participants with DPNP or CIPN

  From index date up to 31st December 2022

• Maximum daily dose in participants with DPNP or CIPN

  From index date up to 31st December 2022

• Time to the maximum daily dose in participants with DPNP or CIPN

  From index date up to 31st December 2022

• Proportion of participants who underwent the daily dose change in participants with DPNP or CIPN

  From index date up to 31st December 2022

Study Arms (2)

Diabetic peripheral neuropathic pain

Participants who have been diagnosed with diabetic peripheral neuropathic pain and presented with pain symptoms.

Other: No Drug

Chemotherapy-induced peripheral neuropathy

Participants who have chemotherapy-induced peripheral neuropathy regardless of the presence of pain symptoms.

Other: No Drug

Interventions

No Drug OTHER

This is an non-interventional, observational study. No drug was administered during this study.

Chemotherapy-induced peripheral neuropathy; Diabetic peripheral neuropathic pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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. 1. Participants were diagnosed with diabetic neuropathy and presented with the pain symptom between 1st January 2018 and 31st December 2021; 2. Participants received at least one targeted medication between 1st January 2018 and 31st December 2021; 3. Participants were ≥18 years on the index date; 4. 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. 1. Participants had neuropathy that was induced by the chemotherapy between 1st January 2018 and 31st December 2021, regardless of the presence of pain symptoms; 2. Participants received at least one targeted medication between 1st January 2018 and 31st December 2021; 3. Participants were ≥18 years on the index date; 4. 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. 1. Participants were diagnosed with epilepsy, schizophrenia, or bipolar disorder before or on the index date; 2. 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.)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Daiichi Sankyo Co., Ltd.: collaborator

Study Sites (10)

China-Japan Friendship Hospital

Beijing, 100013, China

Location

Beijing Hospital

Beijing, 100051, China

Location

Beijing Cancer Hospital

Beijing, 100142, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, 116011, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, 350001, China

Location

Sun Yat-Sen University Cancer Center

Guangzhou, 510060, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, 314408, China

Location

Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)

Jinan, 250117, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, 110000, China

Location

Tongji Hospital Tongji Medical College of Hust

Wuhan, 430030, China

Location

Related Publications (1)

• 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.

  PMID: 40788612 DERIVED

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: August 16, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)