Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China
NCT Number: NCT06546202
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Peripheral Neuropathic Pain|Chemotherapy-induced Peripheral Neuropathy|Neuropathic Pain
Interventions: OTHER: No Drug
Sponsor: Daiichi Sankyo
Collaborators: Daiichi Sankyo (China) Holdings Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-16
Completion Date: 2025-08-30
Locations: China-Japan Friendship Hospital, Beijing, 100013, China|Beijing Hospital, Beijing, 100051, China|Beijing Cancer Hospital, Beijing, 100142, China

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.

Primary Outcome Measures: 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 Outcome Measures: Initial daily dose in participants with DPNP or CIPN, Initial daily dose is defined as the first prescribed daily dose of the targeted medications., 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., 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., 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., From index date up to 31st December 2022