Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-05 @ 5:45 PM
Study NCT ID:
NCT01552395
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2012-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053158', 'term': 'Nocturia'}], 'ancestors': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-23', 'studyFirstSubmitDate': '2012-03-07', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Number of changes in dosage regime', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Nocturia']}, 'descriptionModule': {'briefSummary': 'A Confirmation of the Safety Profile for Minirin Melt in Clinical Practice'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Patients Suffering From Nocturia 1x or More Times a Night', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* nocturia\n\nExclusion Criteria:\n\n* habitual or psychogenic polydipsia,\n* known or suspected cardiac insufficiency\n* other conditions requiring treatment with diuretics\n* moderate and severe renal insufficiency\n* known hyponatremia\n* syndrome of inappropriate ADH secretion'}, 'identificationModule': {'nctId': 'NCT01552395', 'briefTitle': 'A Study of Minirin Melt in 24 Months Treatment in Patients With Nocturia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'A Prospective Safety Study in 24 Months Treatment of Nocturia With Minirin Melt in Clinical Practice in the Czech Republic', 'orgStudyIdInfo': {'id': '000056'}}, 'contactsLocationsModule': {'locations': [{'city': 'Benešov', 'country': 'Czechia', 'facility': 'Nemocnice Rudolfa a Stefanie (there may be other sites in this country)', 'geoPoint': {'lat': 49.78162, 'lon': 14.68697}}, {'city': 'Benešov', 'country': 'Czechia', 'facility': 'Soukromá ambulance, Benešov', 'geoPoint': {'lat': 49.78162, 'lon': 14.68697}}, {'city': 'Beroun', 'country': 'Czechia', 'facility': 'Soukromá ambulance Beroun', 'geoPoint': {'lat': 49.96382, 'lon': 14.072}}, {'city': 'Bohunín', 'country': 'Czechia', 'facility': 'Slezská urologie'}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'URIONTEGRITAS soukromá ambulance', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Uro - clinic', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Urocentrum Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Úrazová nemocnice Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Citonice', 'country': 'Czechia', 'facility': 'Soukromá ambalance', 'geoPoint': {'lat': 48.88395, 'lon': 15.96447}}, {'city': 'Domažlice', 'country': 'Czechia', 'facility': 'Domažlická Nemocnice', 'geoPoint': {'lat': 49.44049, 'lon': 12.92976}}, {'city': 'Dvůr Králové nad Labem', 'country': 'Czechia', 'facility': 'Městská 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'Pilsen', 'country': 'Czechia', 'facility': 'FN Plzeň', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Poliklinika Denisovo nábřeží', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Písek', 'country': 'Czechia', 'facility': 'Nemocnice Písek', 'geoPoint': {'lat': 49.3088, 'lon': 14.1475}}, {'city': 'Prachatice', 'country': 'Czechia', 'facility': 'Urologická ambulance', 'geoPoint': {'lat': 49.01292, 'lon': 13.99752}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'FN Bulovka', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Medicon', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Nemocnice s poliklinikou Praha Italská', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Soukromá ambulance Praha 7', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Soukromá ambulance, Praha 5', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Urocare', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Urologická klinika Praha 1', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Urologické oddělení', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Urologie Zahradní Město s.r.o.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Urosanté s.r.o', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'VFN', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Ústřední vojenská nemocnice', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Praha 10 - Uhříněves', 'country': 'Czechia', 'facility': 'Urologie - NZZ Lékařský dům'}, {'city': 'Přerov', 'country': 'Czechia', 'facility': 'JR Urocentrum Přerov s.r.o.', 'geoPoint': {'lat': 49.45511, 'lon': 17.4509}}, {'city': 'Přeštice', 'country': 'Czechia', 'facility': 'Soukromá ambulance, Přeštice', 'geoPoint': {'lat': 49.57298, 'lon': 13.3335}}, {'city': 'Říčany', 'country': 'Czechia', 'facility': 'Urocare s.r.o.', 'geoPoint': {'lat': 49.99168, 'lon': 14.65427}}, {'city': 'Štemberk', 'country': 'Czechia', 'facility': 'Soukromá ambulance Štemberk'}, {'city': 'Tábor', 'country': 'Czechia', 'facility': 'Nemocnice Tábor', 'geoPoint': {'lat': 49.41441, 'lon': 14.6578}}, {'city': 'Teplice', 'country': 'Czechia', 'facility': 'Krajská zdravotní - nemocnice Teplice', 'geoPoint': {'lat': 50.6404, 'lon': 13.82451}}, {'city': 'Trutnov', 'country': 'Czechia', 'facility': 'Urologická ambulance', 'geoPoint': {'lat': 50.56101, 'lon': 15.9127}}, {'city': 'Třebíč', 'country': 'Czechia', 'facility': 'Nemocnice Třebíč', 'geoPoint': {'lat': 49.21492, 'lon': 15.88166}}, {'city': 'Třinec', 'country': 'Czechia', 'facility': 'Nemocnice Podlesí a.s.', 'geoPoint': {'lat': 49.67763, 'lon': 18.67078}}, {'city': 'Turnov', 'country': 'Czechia', 'facility': 'Městská nemocnice Turnov', 'geoPoint': {'lat': 50.58356, 'lon': 15.15186}}, {'city': 'Uherské Hradiště', 'country': 'Czechia', 'facility': 'Nemocnice Uherské Hradiště', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Masarykova nemocnice v Ústí nad Labem', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'city': 'Valašské Meziříčí', 'country': 'Czechia', 'facility': 'Nemocnice Valašské Meziříčí', 'geoPoint': {'lat': 49.47181, 'lon': 17.97113}}, {'city': 'Zlín', 'country': 'Czechia', 'facility': 'DUAM s.r.o. 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