No drug
OtherThis is an non-interventional, observational study. No drug was administered during this study.
NCT Number: NCT06546202
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.
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Notify Me18 year and older
All sexes
Observational
Beijing Cancer Hospital, Beijing, China
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Participants who meet all the following criteria will be included in the DPNP cohort.
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 who meet any one of the following criteria will be excluded from the CIPN cohort.
This is an non-interventional, observational study. No drug was administered during this study.
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.
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).
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.
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 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.
Time frame: From index date up to 31st December 2022
Initial daily dose is defined as the first prescribed daily dose of the targeted medications.
Time frame: From index date up to 31st December 2022
Maximum daily dose is defined as the maximum of the daily dose.
Time frame: 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.
Time frame: 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.
Daiichi Sankyo
Industry
Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multi-center Study (ReTARdant)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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