A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia

Completed

• Conditions: Nocturia

• Registration Number: NCT01552395
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4136

Inclusion Criteria

• nocturia

Exclusion Criteria

• habitual or psychogenic polydipsia,
• known or suspected cardiac insufficiency
• other conditions requiring treatment with diuretics
• moderate and severe renal insufficiency
• known hyponatremia
• syndrome of inappropriate ADH secretion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	24 months

Secondary Outcome Measures

Name	Time	Method
Number of changes in dosage regime	24 months

Trial Locations

Locations (67)

Nemocnice Rudolfa a Stefanie (there may be other sites in this country); 🇨🇿 Benešov, Czech Republic

Soukromá ambulance, Benešov; 🇨🇿 Benešov, Czech Republic

Soukromá ambulance Beroun; 🇨🇿 Beroun, Czech Republic

Slezská urologie; 🇨🇿 Bohunín, Czech Republic

URIONTEGRITAS soukromá ambulance; 🇨🇿 Brno, Czech Republic

Uro - clinic; 🇨🇿 Brno, Czech Republic

Urocentrum Brno; 🇨🇿 Brno, Czech Republic

Úrazová nemocnice Brno; 🇨🇿 Brno, Czech Republic

Soukromá ambalance; 🇨🇿 Citonice, Czech Republic

Domažlická Nemocnice; 🇨🇿 Domažlice, Czech Republic

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