Study of Minirin Melt® in Adult Patients With Nocturia

Nocturia Clinical Trial

Official title:

Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03089073
• Other study ID #: 000208
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Nocturia

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