A Phase II, 4-Week Randomised, Double-Blind, Parallel Group, Placebo Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of GRC 17536 in Patients with Painful Diabetic Peripheral Neuropathy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 10
- 主要终点
- Mean 24-hour average pain intensity (API) score
研究概览
简要总结
Diabetic peripheral neuropathy (DPN) represents a diffuse symmetric and length-dependent injury to peripheral nerves that has major implications on quality of life (QOL), morbidity, and costs from a public health perspective. Painful diabetic neuropathy affects approximately 16% of patients with diabetes. Pharmacological agents used in the management of painful DPN mainly include tricyclic antidepressants, selective serotonin and norepinephrine reuptake inhibitors, opioid, and anti epileptic drugs. The available treatment options do not give total relief, are not effective in all patients, and only about one-third of patients may achieve more than 50% pain relief. Hence newer therapies are required for the treatment of DPN.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The study will be conducted in 10 centres in India, and 1 each, in Germany and the UK.
The primary outcome measures will be the change from baseline to end of treatment in the mean 24-hour average pain intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to provide voluntary written informed consent 2.Male and female (women of non child-bearing potential) patients ≥18 yrs and ≤75 yrs 3.Patients with diabetes mellitus with painful peripheral neuropathy for at least 6 months 4.A baseline 24-hour average daily pain intensity score ≥5 5.Women must be of non child-bearing potential, defined as post menopausal or surgically sterile.
排除标准
- •1.Other chronic pain conditions not associated with DPN, that may confound the assessment of neuropathic pain 2.Other causes of neuropathy or lower extremity pain 3.Complex regional pain syndrome or trigeminal neuralgia 4.Lower extremity amputations other than toes 5.Participation in another study with an investigational compound within the previous 90 days prior to study medication administration, or concurrent participation in another clinical study 6.Major depression.
- •7.Presence or history of cancer within the past 5 years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
- •8.Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition that according to Investigators medical judgment: Could interfere with the accurate assessment of safety or efficacy, or, Could potentially affect a patients safety or study outcome.
结局指标
主要结局
Mean 24-hour average pain intensity (API) score
时间窗: Time Frame: 4 weeks
次要结局
- Mean night-time API Score(Time Frame: 4 weeks)
- Patient Global Impression of Change(Time Frame: 4 weeks)
- Clinician Global Impression of Change(Time Frame: 4 weeks)