NCT01089855已完成4 期
Phase IV Open Non Comparative Trial to Evaluate Efficacy and Safety of Tegretol® in Diabetes Neuropathy Pain.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)
研究概览
简要总结
The trial is designed to evaluate the efficacy and tolerability of carbamazepine in neuropathic pain in diabetic patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes patients with Diabetes neuropathy DN4 > or equal to 4
- •Male or female aged from 21 to 65 years
- •Informed consent
- •HbA1C < 11%
排除标准
- •Prior Hospitalization for Acido- cetosis
- •Prior hospitalization for severe hypoglycemia
- •Pregnancy
- •Hepatitis
- •Diabetes foot
- •AVB (auriculo-ventricular conduction disturbance)
- •Patient treated by antidepressant drugs
- •Patient treated with other antiepileptic drug
- •Patients with blood ion disturbance
- •Patient with neutropenia
- •Bladder Adenoma
- •Alcohol abuse
- •Creatinin clearance < 60 ml/ minute
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Carbamazepine
Experimental
干预措施: Carbamazepine (Drug)
结局指标
主要结局
The decrease of neuropathic pain in diabetic patients using Brief Pain Inventory scale (BPI)
时间窗: 12 weeks
次要结局
- Evaluate the tolerability of carbamazepine (including Adverse Events, Serious Adverse Events and abnormal laboratory finding)(12 weeks)
- Evaluate the quality of life(12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Paracetamol as Antipyretic and Analgesic MedicationFeverAnalgesiaNCT01070732University of Athens100
终止
2 期
A Randomized, Double-Blind, Placebo Controlled, Multicenter, Efficacy and Safety Trial of Single Cycle Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic PainChemotherapy-induced Neuropathic PainChemotherapy-induced Peripheral NeuropathyNCT05359133Wex Pharmaceuticals Inc.35
已完成
1 期
Safety and Pharmacokinetics of KBPA-101 in Hospital Acquired Pneumonia Caused by O11 Pseudomonas AeruginosaVentilator Associated PneumoniaPneumoniaNCT00851435Kenta Biotech Ltd15
终止
2 期
A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983YPainful Diabetic NeuropathyNCT01056315Grünenthal GmbH553
终止
不适用
Clinical Management of Neuropathic Pain With RamelteonNeuropathic PainNCT00753623Massachusetts General Hospital23