DRUG
Desmopressin
60μg or 120μg once daily at bedtime
Study of Minirin Melt® in Adult Patients With Nocturia
Status
Terminated
Phase
Not applicable
Enrollment
835
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 24, 2017
Study start
Jul 13, 2015
Primary completion
Oct 5, 2018
Study completion
Oct 5, 2018
Results posted
Not reported
Registry updated
Feb 5, 2021
Outcomes
What the study measures.
Primary outcomes
Change from baseline in mean number of nocturnal voids
Time frame · Baseline and treatment-related visits up to 3 months
Calculated by 72 hour frequency volume chart (FVC)
Secondary outcomes
Reduction from baseline in the mean number of nocturnal voids
Time frame · Baseline and treatment-related visits up to 3 months
Assessed as a (50% decrease) or reduction of nocturnal diuresis (\>20%)
Eligibility
Who can take part.
- Minimum age
- 19 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Adult aged between 19 and 65 years * Patients having nocturia * Decision made to prescribe Minirin Melt according to prescription information * Willingness and ability to provide written informed consent Exclusion Criteria: * When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours) * When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis * When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min) * When patients have known hyponatremia * When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) * When patients have hypersensitivity to the active substances or to any of the excipients
Study locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Daegu Fatima Hospital (there may be other sites in this country)
Daegu, South Korea
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.