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Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia)

NCT ID: NCT04329975

Last Updated: 2024-12-20

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

COMPLETED

Total Enrollment

1087 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-19

Study Completion Date

2024-09-25

Brief Summary

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To investigate the incidence and risk factors of desmopressin-induced hyponatremia during long-term treatment (1 year \[52 weeks\]) of MINIRINMELT orally disintegrating (OD) tablets 25μg/50μg (drug) for nocturia caused by nocturnal polyuria in men in daily clinical practice, and to confirm the compliance with proper use of this drug in clinical practice and to investigate the effectiveness of risk minimization activities.

Detailed Description

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Conditions

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Nocturia Due to Nocturnal Polyuria

Keywords

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Hyponatremia Long-term treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Nocturia

Participants with nocturia due to nocturnal polyuria treated with MINIRINMELT OD Tablet 25μg or 50μg as per daily clinical practice.

Desmopressin

Intervention Type DRUG

Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.

Interventions

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Desmopressin

Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.

Intervention Type DRUG

Other Intervention Names

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MINIRINMELT

Eligibility Criteria

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Inclusion Criteria

* Participants who received the MINIRINMELT for the first time in men with nocturia due to nocturnal polyuria, an indication for drug.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

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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Survey Site (there may be other sites in this country)

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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000346

Identifier Type: -

Identifier Source: org_study_id