Study of Minirin Melt® in Adult Patients With Nocturia

N/ATerminatedNCT03089073

Ferring Pharmaceuticals835 enrolled

Overview

Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia

Study Type

OBSERVATIONAL

Enrollment

835

Conditions

Nocturia

Interventions

DesmopressinDRUG

60μg or 120μg once daily at bedtime

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Daegu Fatima Hospital (there may be other sites in this country)

Daegu, South Korea

Outcomes

Primary Outcomes

Change from baseline in mean number of nocturnal voids

Calculated by 72 hour frequency volume chart (FVC)

Time frame: Baseline and treatment-related visits up to 3 months

Secondary Outcomes

Reduction from baseline in the mean number of nocturnal voids

Assessed as a (50% decrease) or reduction of nocturnal diuresis (\>20%)

Time frame: Baseline and treatment-related visits up to 3 months

Data from ClinicalTrials.gov

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