The Use of QUTENZA™ in Standard Clinical Practice: a Phase IV, Multicentre, European Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 429
- 试验地点
- 50
- 主要终点
- Percent change in average pain NPRS (Numeric Pain Rating Scale) scores
研究概览
简要总结
This non-interventional study will evaluate the efficacy, tolerability, health related quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is used in standard clinical practice.
The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back pain; cancer-related neuropathic pain; post-operative & post-traumatic neuropathic pain; and 'other' neuropathies.
详细描述
A detailed medical history will be taken, with particular emphasis on the primary PNP diagnosis. In addition to all current neuropathic pain medications, all previous therapies (pharmacological and surgical) for PNP from the point of primary diagnosis will be documented.
QUTENZA treatments may be repeated up to every 90 days, in line with the Summary of Product Characteristics document (SPC) as determined by the persistence or return of pain.
Patients who have not required treatment for 365 days or longer may re-enter a treatment cycle if their treating physician decides to retreat them with QUTENZA in the course of standard clinical management.
The duration of participation for each patient will be at least 12 months following first QUTENZA treatment.
Short questionnaires will be completed by the investigator whilst in contact with the patient (either in person or by telephone) at the following time points: 1) Screening prior to the first QUTENZA treatment; 2) at each QUTENZA treatment visit; 3) 2 weeks, 8 weeks following the first QUTENZA treatment 4) 12 weeks following each QUTENZA treatment; 5) any additional contact with the patient outside the protocol schedule.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The investigator has decided to treat the patient with QUTENZA as part of provision of standard care for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain
- •The patient is willing and able to comply with protocol requirements for the duration of study participation
排除标准
- •The neuropathic painful areas are located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
- •The patient has a history of Type I or Type II diabetes mellitus
- •The patient has a diagnosis of any major psychiatric disorder or evidence of cognitive impairment including dementia that, in the opinion of the investigator, may interfere with patient's ability to complete study evaluations
- •The patient has received any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial
- •The patient has hypersensitivity to capsaicin (i.e. chilli peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients or adhesives, or local anesthetics
- •The patient has participated in any other clinical study or received an investigational drug within 30 days prior to Screening Visit
- •The patient currently engages in any active substance abuse or has a history of chronic substance abuse within 1 year prior to the Screening Visit; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
- •The patient, in the opinion of the investigator, is not suitable to participate in this NIS for any reason
研究组 & 干预措施
Treatment with QUTENZA
Patients with Peripheral Neuropathic Pain
干预措施: Qutenza exposure (Drug)
结局指标
主要结局
Percent change in average pain NPRS (Numeric Pain Rating Scale) scores
时间窗: From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment
Time to retreatment
时间窗: Between 1st & 2nd treatments (up to a maximum of 24 months)
From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
次要结局
- Proportion of patients achieving 50% decrease in average pain NPRS score(From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment)
- Absolute change in "average pain" NPRS score(From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s))
- Proportion of patients achieving 30% decrease in average pain NPRS score(From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment)
- Proportion of patients achieving a 30% decrease in their "average pain" NPRS score (maintenance response)(From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s))
- Percent change in "average pain" NPRS score(From baseline to mean of all scores between Week 2 and Week 8 and Weeks 2 and Week 12 following retreatment(s))
- Change in health-related quality of life(From baseline to End of Study (up to 24 months))
- Patient Global Impression of Change(At each follow-up after 1st and subsequent treatment(s) (up to a maximum of 24 months))
- Change in Work Productivity and Activity Impairment scores(Baseline, week 12, 6 months, 9 months, and 12 months after 1st and subsequent treatment(s))
- Proportion of patients achieving a 50% decrease in their "average pain" NPRS score (maintenance response)(From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s))
- Mean "Average pain" NPRS score(At each time point following 1st and subsequent treatment(s) (up to a maximum of 24 months))
- Patient Self Assessment of Treatment(At 12 weeks, 6 months, 9 months, and 12 months after 1st and subsequent retreatment(s))
- Number of QUTENZA patches used with each treatment(Day 1 of each treatment)
- Change in health resource use(From baseline to End of Study (up to 24 months))
- Percentage of patients requiring rescue measures during and after treatment with QUTENZA(From Baseline to End of Study (up to 24 months))
- Relative change in treatment area size(At first treatment and each retreatment (up to a maximum of 24 months))
- Change in concomitant pain medications(From baseline to End of Study (up to 24 months))
- Proportion of patients achieving a 2-point absolute decrease in their "average pain" NPRS score(From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s))
- Time (in days) between successive retreatments(Between successive retreatments (up to a maximum of 24 months))