A comparative single blind, Parallel group, non-crossover, multi-centric clinical trial of Amitriptyline 4% + Ketamine 2 % Cream in patients having Neuralgia due to diabetes, chemotherapy or shingles.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- A comparative evaluation of efficacy of Amitriptyline 4% + Ketamine 2% Cream, with Capsaicin Cream 0.025%, in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles.
研究概览
简要总结
This study is a single blind, placebo controlled, non-crossover, multi-centric clinical trial of Amitriptyline 4% + Ketamine 2 % Cream in adult patients having Neuralgia due to diabetes, chemotherapy or shingles that will be conducted in 2 centers of India. Test Drug or Reference Drug will be applied twice daily to the areas of worst pain for 4 weeks in 100 patients. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary outcome measures will be assessed by in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles. At 0 Day, Week 1, Week 2, Week 3, Week 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Patient with history, signs & symptoms of peripheral neuropathies due to diabetes, chemotherapy or shingles.
排除标准
- •Patients < 18 & > 60 years
- •History of hypersensitivity to the study drug or similar class of drug.
- •Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications.
- •Pregnant or lactating women.
- •Patients with serum creatinine greater than 2.5 mg/dl.
- •Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits
- •Significant history or presence of glaucoma, cardiovascular or hematological disease.
- •Any clinical significant illness during the 4 weeks prior to day 1 of this study.
- •Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease.
- •Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study.
- •Use of enzyme-modifying drugs within 30 days prior to day 1 of this study.
- •HIV and Australian Antigen positive subjects.
- •Any condition that, in the opinion of the investigator, does not justify the patients inclusion in the study.
结局指标
主要结局
A comparative evaluation of efficacy of Amitriptyline 4% + Ketamine 2% Cream, with Capsaicin Cream 0.025%, in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles.
时间窗: Day 0, 1st Week, 2nd Week, 3rd Week, 4th Week.
次要结局
- A comparative evaluation of safety & tolerability of Amitriptyline 4% + Ketamine 2% Cream, with Capsaicin Cream 0.025%, in adult patients suffering from Neuralgia due to diabetes, chemotherapy or shingles.(Day 0, 1st Week, 2nd Week, 3rd Week, 4th Week.)