NCT06324123已完成不适用
Observational Study Aimed at Evaluating the Trend of Neuropathic Pain Through the Reduction of the NRS Questionnaire Score in Patients Treated With PEACETIL
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 3
- 主要终点
- Change in neuropathic pain after two months of treatment with Peacetil
研究概览
简要总结
The present study aims to evaluate the trend of neuropathic pain in patients treated with Peacetil for a period of two months.
Neuropathic pain will me assessed through the Numeric Rating Scale (NRS) questionnaire score.
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 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with new or recent diagnosis of acute or chronic neuropathic pain in which the clinician decides to introduce treatment with PEACETIL according to common clinical practice, belonging to one of the following categories:
- •Dysmetabolic polyneuropathy (e.g. diabetic neuropathy),
- •Chemotherapy treatment neuropathy,
- •Compressive mononeuropathy,
- •Radiculopathy,
- •Postherpetic and non-postherpetic trigeminal neuralgia;
- •The patient must be able to understand the informed consent of the study;
- •Must adhere to the procedures established by the study;
- •DN4 score >4 at T0 (month 0);
排除标准
- •Neurological disorders confounding the primary objective;
- •Clinical condition which during the observational study requires the introduction or modification of the dosage of drugs which are also indicated for the treatment of acute or chronic pain
- •Introduction or modification of the dosage of drugs used to treat acute and chronic neuropathic pain (including other nutraceuticals) from 30 days before the start of the study until the end of the study.
- •Presence of unstable psychiatric illness, cognitive impairment, dementia, or substance abuse that would compromise the participant's ability to provide informed consent, as judged by the investigator;
- •Clinically significant unstable medical condition (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, serious laboratory test abnormality, or clinically significant ECG changes) that would pose a risk to the participant if they were to participate in the study, in the judgment of the 'investigator.
结局指标
主要结局
Change in neuropathic pain after two months of treatment with Peacetil
时间窗: At enrollment and at two months after the start of treatment with Peacetil
Assessed by the Numerical Rating Scale (NRS) score
次要结局
- Change in neuropathic pain after one month of treatment with Peacetil(At enrollment and at one month after the start of treatment with Peacetil)
研究者
研究点 (3)
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