Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China
- Conditions
- Neuropathic PainChemotherapy-induced Peripheral NeuropathyDiabetic Peripheral Neuropathic Pain
- Interventions
- Other: No Drug
- Registration Number
- NCT06546202
- Lead Sponsor
- Daiichi Sankyo
- 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chemotherapy-induced peripheral neuropathy No Drug Participants who have chemotherapy-induced peripheral neuropathy regardless of the presence of pain symptoms. Diabetic peripheral neuropathic pain No Drug Participants who have been diagnosed with diabetic peripheral neuropathic pain and presented with pain symptoms.
- Primary Outcome Measures
Name Time Method Proportion of participants who restarted treatment after discontinuation in participants with DPNP or CIPN 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 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.
Proportion of participants who discontinue/switch/add-on treatment and related medication categories in participants with DPNP or CIPN 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 β₯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 receiving different treatment regimens (targeted medications or combinations) and related medication categories in participants with DPNP or CIPN 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.
Time to treatment add-on in participants with DPNP or CIPN 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.
- Secondary Outcome Measures
Name Time Method Initial daily dose in participants with DPNP or CIPN From index date up to 31st December 2022 Initial daily dose is defined as the first prescribed daily dose of the targeted medications.
Maximum daily dose in participants with DPNP or CIPN From index date up to 31st December 2022 Maximum daily dose is defined as the maximum of the daily dose.
Proportion of participants who underwent the daily dose change in participants with DPNP or CIPN From index date up to 31st December 2022 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.
Time to the maximum daily dose in participants with DPNP or CIPN From index date up to 31st December 2022 Time to the maximum daily dose is defined as the time interval between the daily dose to the maximum daily dose.
Trial Locations
- Locations (10)
The First Affiliated Hospital of Dalian Medical University
π¨π³Dalian City, China
China-Japan Friendship Hospital
π¨π³Beijing, China
Beijing Hospital
π¨π³Beijing, China
Beijing Cancer Hospital
π¨π³Beijing, China
The First Affiliated Hospital of Fujian Medical University
π¨π³Fuzhou City, China
Sun Yat-Sen University Cancer Center
π¨π³Guangzhou City, China
Zhejiang Provincial People's Hospital
π¨π³Hangzhou City, China
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
π¨π³Jinan City, China
Liaoning Cancer Hospital & Institute
π¨π³Shenyang City, China
Tongji Hospital Tongji Medical College of Hust
π¨π³Wuhan City, China