A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension study - Melatonin for Nocturia in MS

orth Bristol NHS Trust0 个研究点目标入组 80 人开始时间: 2012年12月14日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•- Over 18 years old
•- Confirmed neurological diagnosis of multiple sclerosis
•- At least 1 episode of nocturia (as defined by International Continence Society criteria [6]) every night
•- Female subjects of child-bearing potential; willing to use an effective method of contraception throughout the study
•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 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- Under 18 years old
•- Pregnant patients
•- Symptomatic urinary infection
•- Indwelling urinary catheter
•- Use of desmopressin or investigational medical compounds in the month preceding randomization
•- Antimuscarinic or diuretic medication, unless used long-term prior to study (at least 3 months) and continued at same dosing regime throughout the study
•- Use of melatonin on prescription, or purchased over-the-counter/ online
•- Use of sleeping tablets” on prescription, or purchased over-the-counter/ online
•- Diabetes mellitus
•- Diabetes insipidus
•- Unwilling to give informed consent
•- Female subjects of child-bearing potential; unwilling to use an effective method of contraception throughout the study

发起方

orth Bristol NHS Trust