2024-511008-17-00招募中4 期
(LAX) A Randomized, open label, Non-inferiority trial on the efficacy of Lacosamide versus Duloxetine in Patients with Chemotherapy-induced Polyneuropathy - A strategy trial
Leids Universitair Medisch Centrum (LUMC)1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年7月29日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Pain intensity score during the last 4 weeks of treatment
研究概览
简要总结
To explore the analgesic effect of lacosamide compared to duloxetine in patients with painful chemotherapy-induced polyneuropathy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •Able to give oral and written informed consent
- •Indications of small- or large fiber neuropathy with quantitative sensory testing (compared to healthy population).
- •Pain score of 4 or higher
- •Chemotherapy with taxanes, platinums, vicalkiniods or bortezomib in the past
- •Presence of symptoms of neuropathic pain at least 3 months after the last chemotherapy
排除标准
- •Allergy to the study medication
- •Kidney dysfunction (GFR < 30 mL/min)
- •Severe heart failure (e.g. as a result of infarction or a structural heart defect)
- •Heart Rhythm Disorders (including 2nd or 3rd degree atrioventricular (AV) block and sodium channelopathies.
- •Systolic blood pressure above 180mm Hg with current antihypertensive medications (according to screening measurement)
- •Any condition that by the judgement of the investigator might interfere with the investigation
- •History of illicit drug or alcohol abuse
- •History of psychosis
- •Pregnancy or lactation
- •Use of anti-epileptic or anti-depressant medication (in particular MAO inhibitors)
- •Use of CYP1a2 inhibitors (e.g. fluvoxamine, fluocinolone, cimetidine)
- •Concomitant neuropathy other than chemotherapy-induced
- •Moderate and severe liver enzyme abnormalities
结局指标
主要结局
Pain intensity score during the last 4 weeks of treatment
Pain intensity score during the last 4 weeks of treatment
次要结局
- Patient satisfaction of treatment
- Side effect profile
研究者
Marieke Niesters
Scientific
Leids Universitair Medisch Centrum (LUMC)
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor. Compare the Efficacy and Adverse EffectsNCT07264309Zohar Nachum140
进行中（未招募）
2 期
PZH2108 片 IIa 期临床研究CTR2025277572
已完成
不适用
硫酸吗啡缓释片治疗慢性癌性疼痛有效性和安全性的研究CTR20131083240
撤回
4 期
"Efficacy and safety of Balanced Analgosedation in Bronchoscopy with Propofol/Pethidine versus Midazolam/Pethidine: a single-centre randomised controlled trial (ABroProMida Study)"2024-518820-65-00Azienda Unita' Sanitaria Locale Toscana Sud Est530
招募中
2 期
Analgesic effect of intravenous lidocaïne and its mechanisms in patients suffering from chronic inflammatory bowel disease (IBD) with abdominal pain.2023-508224-35-01CHU De Liege80