Pain relief with disease modification by Capsaicin 8% patch: a clinical study in Diabetic Peripheral Neuropathy - Capsaicin 8% patch: a clinical study in Diabetic Peripheral Neuropathy

Joint Research Compliance Office, Imperial College London and Imperial College Healthcare NHS Trust0 个研究点目标入组 50 人开始时间: 2018年6月30日最近更新: 2018年7月23日

试验速览

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•1. Participants aged 18-80 years with painful distal, symmetrical, sensorimotor
•polyneuropathy due to type 2 Diabetes of at least 1-year duration.
•2. Stable control for at least 3 months of type 2 Diabetes mellitus.
•3. Glycosylated haemoglobin (hbA1c) of = 9%.
•4. Willing to provide written informed consent to participate in the study.
•5. Patients with a history of pain intensity equal or greater than 4 NPRS points (as
•determined by the NPRS study diary at baseline) are eligible to participate.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1. Non-diabetic neuropathies
•2.History of alcohol/substance abuse
•3.History of severe psychiatric illnesses
•4.Pregnancy/breast feeding or planning pregnancy during the course of the study
•5.Significant renal impairment (eGFR <30mL/minute/1.73m2)
•6.Heart failure New York Heart Association (NYHA) = class II
•7.Any other painful medical conditions that may interfere with the assessment
•of change in neuropathic pain.
•In addition to the exclusion criteria above patients who are participating in another clinical trial or who have done so within 30 days before screening will be considered as not eligible for the study.

发起方

Joint Research Compliance Office, Imperial College London and Imperial College Healthcare NHS Trust