A randomised, double blind, placebo controlled, crossover trial of melatonin for treatment of nocturia in adults with multiple sclerosis

orth Bristol NHS Trust (UK)0 个研究点目标入组 50 人开始时间: 2013年4月4日最近更新: 2018年8月27日

适应症

试验速览

•1. Male and female over 18 years old, upper age limit 80 years
•2. Confirmed neurological diagnosis of multiple sclerosis.
•3. At least 1 episode of nocturia (as defined by International Continence Society criteria [6]) every night.
•4. Female subjects of childbearing potential; willing to use an effective method of contraception throughout the study.

•1. Under 18 years old
•2. Pregnant patients
•3. Symptomatic urinary infection
•4. Indwelling urinary catheter
•5. Use of desmopressin or investigational medical compounds in the month preceding randomisation
•6. Antimuscarinic or diuretic medication, unless used longterm prior to study (at least 3 months) and continued at same dosing regime throughout the study
•7. Use of melatonin on prescription, or purchased over the counter/online
•8. Use of ?sleeping tablets? on prescription, or purchased overt he counter/ online
•9. Diabetes mellitus
•10. Diabetes insipidus
•11. Unwilling to give informed consent
•12. Female subjects of childbearing potential; unwilling to use an effective method of contraception throughout the study

发起方

orth Bristol NHS Trust (UK)