ISRCTN38687869
Completed
未知
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 sites50 target enrollmentApril 4, 2013
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Topic: Renal and Urogenital, Nocturia in adults with multiple sclerosis
- Sponsor
- orth Bristol NHS Trust (UK)
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28347292 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30081859
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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