Specified Drug Use-results Survey (Long-term Use) on MINIRINMELT® OD Tablet (Nocturia) (NOC01)

Ferring

Status: Completed

Conditions: Nocturia Due to Nocturnal Polyuria

Treatments: Drug: Desmopressin

Study type: Observational

Funder types: Industry

Identifiers

NCT04329975

000346

Details and patient eligibility

About

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.

Enrollment: 1,087 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• No exclusion criteria defined for this study.

Trial design

1,087 participants in 1 patient group

Participants with Nocturia

Description:

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

Treatment:

Drug: Desmopressin