Study of Minirin Melt® in Adult Patients With Nocturia

NCT ID: NCT03089073

Last Updated: 2021-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

835 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-13

Study Completion Date

2018-10-05

Brief Summary

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

Detailed Description

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Conditions

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Nocturia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Desmopressin

60μg or 120μg once daily at bedtime

Intervention Type DRUG

Other Intervention Names

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Minirin Melt®

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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000208

Identifier Type: -

Identifier Source: org_study_id

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