Clinical trial NCT06546202: Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China
Official title: Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multi-center Study (ReTARdant)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Peripheral Neuropathic Pain
Chemotherapy-induced Peripheral Neuropathy
Neuropathic Pain
Keywords: Diabetic peripheral neuropathic pain
Chemotherapy-induced peripheral neuropathy
Neuropathic pain
Treatment pattern
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo (China) Holdings Co., Ltd.
First posted: 2024-08-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

Eligibility criteria: 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.)

Primary outcomes:
measure: Proportion of participants receiving different treatment regimens (targeted medications or combinations) and related medication categories in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
measure: Proportion of participants who discontinue/switch/add-on treatment and related medication categories in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
measure: Proportion of participants who restarted treatment after discontinuation in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
measure: Duration of the current treatment in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
measure: Time to treatment add-on in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
Secondary outcomes:
measure: Initial daily dose in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
measure: Maximum daily dose in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
measure: Time to the maximum daily dose in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
measure: Proportion of participants who underwent the daily dose change in participants with DPNP or CIPN
timeFrame: From index date up to 31st December 2022
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Dalian City
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Fuzhou City
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou City
country: China
facility: Sun Yat-Sen University Cancer Center
city: Hangzhou City
country: China
facility: Zhejiang Provincial People's Hospital
city: Jinan City
country: China
facility: Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute, Shandong Cancer Hospital)
city: Shenyang City
country: China
facility: Liaoning Cancer Hospital & Institute
city: Wuhan City
country: China
facility: Tongji Hospital Tongji Medical College of Hust
Study officials:
References: