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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03089073
Other study ID # 000208
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 13, 2015
Est. completion date October 5, 2018

Study information

Verified date February 2021
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 835
Est. completion date October 5, 2018
Est. primary completion date October 5, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Desmopressin
60µg or 120µg once daily at bedtime

Locations

Country Name City State
Korea, Republic of Daegu Fatima Hospital (there may be other sites in this country) Daegu

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in mean number of nocturnal voids Calculated by 72 hour frequency volume chart (FVC) Baseline and treatment-related visits up to 3 months
Secondary Reduction from baseline in the mean number of nocturnal voids Assessed as a (50% decrease) or reduction of nocturnal diuresis (>20%) Baseline and treatment-related visits up to 3 months
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