Clinical trial NCT00902265: Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)
Official title: Efficacy and Safety of Nocturin 0.1 mg Tablets in Treatment of Nocturia in Patients With Nocturnal Polyuria, Lower Urinary Tract Symptoms (LUTS) and Benign Prostate Syndrome (BPS).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturia Associated With Nocturnal Polyuria
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 138
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: private practices

Brief summary: Documentation of the efficacy and safety of desmopressin (Nocturin®) 0.1 mg tablet. Observation of patients with benign prostate syndrome, in whom nocturia associated with nocturnal polyuria is treated with desmopressin (Nocturin®) 0.1 mg tablet focusing on number of nocturnal voids, ratio of night/24-h urine volume (%), duration of first undisturbed sleep period and quality of life.


Eligibility criteria: Inclusion Criteria:

* Therapeutic need according to Summary of Product Characteristics
* Written informed consent

Exclusion Criteria:

* Contraindications according to Summary of Product Characteristics

Primary outcomes:
measure: Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Degree of Bother Due to Frequency of Daytime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Degree of Bother Due to Frequency of Nighttime Voiding Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N)at Week 12
timeFrame: Baseline, Week 12
measure: Participants With Treatment Emergent Adverse Events (AEs)
timeFrame: Week 1 to Week 12
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Investigational Site - Pauwelsstraße 30
city: Aachen
country: Germany
facility: Investigational Site - Sanatoriumstraße 10
city: Arnsberg
country: Germany
facility: Investigational Site
city: Bad Bergzabern
country: Germany
facility: Investigational Site
city: Bad Schönborn
country: Germany
facility: Investigational Site
city: Baierbrunn
country: Germany
facility: Investigational Site
city: Bergisch Gladbach
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site - Breite Straße 37
city: Berlin
country: Germany
facility: Investigational Site - Britzer Damm 63
city: Berlin
country: Germany
facility: Investigational Site - Florastraße 44
city: Berlin
country: Germany
facility: Investigational Site - Fritz-Reuter-Straße 6-8
city: Berlin
country: Germany
facility: Investigational Site - Heerstraße 435
city: Berlin
country: Germany
facility: Investigational Site - Kaiserdamm 12
city: Berlin
country: Germany
facility: Investigational Site - Kurfürstendamm 33
city: Berlin
country: Germany
facility: Investigational Site - Marburger Straße 12/13
city: Berlin
country: Germany
facility: Investigational Site - Mehrower Allee 22
city: Berlin
country: Germany
facility: Investigational Site - Rüdesheimer Straße 43
city: Berlin
country: Germany
facility: Investigational Site - Schnellerstraße 123
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country: Germany
facility: Investigational Site - Tempelhofer Damm 214
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facility: Investigational Site - Turmstraße 82
city: Biberach
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city: Bochum
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city: Bonn
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city: Braunschweig
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facility: Investigational Site - Friedrich-Wilhelm-Str. 43/44
city: Braunschweig
country: Germany
facility: Investigational Site - Güldenstraße 19-20
city: Braunschweig
country: Germany
facility: Investigational Site - Humboldtstraße 4
city: Braunschweig
country: Germany
facility: Investigational Site - Küchenstraße 10
city: Braunschweig
country: Germany
facility: Investigational Site - Ritterbrunnen 7
city: Bremerhaven
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facility: Investigational Site - Dr.-Franz-Mertens-Str. 8
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facility: Investigational Site - Georgstraße 44
city: Bruchköbel
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city: Butzbach
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city: Celle
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facility: Investigational Site - Großer Plan 11
city: Celle
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facility: Investigational Site - Neumarkt 1d
city: Cottbus
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city: Dorsten
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city: Dortmund
country: Germany
facility: Investigational Site - Hansastraße 14-16
city: Dortmund
country: Germany
facility: Investigational Site - Markt 4
city: Dortmund
country: Germany
facility: Investigational Site - Wittbräucker Str. 2
city: Düsseldorf
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city: Eisenberg
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city: Essen
country: Germany
facility: Investigational Site - Altessener Str. 400a
city: Essen
country: Germany
facility: Investigational Site - Gerichtsstraße 32
city: Essen
country: Germany
facility: Investigational Site - Humannstraße 3
city: Essen
country: Germany
facility: Investigational Site - Rüttenscheider Stern 5
city: Frankfurt /Main
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facility: Investigational Site - Ginnheimer Landstraße 88
city: Frankfurt a.M.
country: Germany
facility: Investigational Site - Bologarostraße 131
city: Frankfurt a.M.
country: Germany
facility: Investigational Site - Eschersheimer Landstr. 544
city: Frankfurt a.M.
country: Germany
facility: Investigational Site - Oeder Weg 72
city: Gardelegen
country: Germany
facility: Investigational Site
city: Gelsenkirchen
country: Germany
facility: Investigational Site - Zum Ehrenmal 21
city: Gera
country: Germany
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country: Germany
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city: Halle
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facility: Investigational Site - Diesterwegstraße 39
city: Halle
country: Germany
facility: Investigational Site - Nimeyerstraße 23
city: Hamburg
country: Germany
facility: Investigational Site - Grindelberg 3
city: Hamburg
country: Germany
facility: Investigational Site - Möllner Landstraße 27
city: Hannover
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country: Germany
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city: Jena
country: Germany
facility: Investigational Site - Dornburger Straße 17a
city: Jena
country: Germany
facility: Investigational Site - Ernst-Abbe-Platz 3-4
city: Jena
country: Germany
facility: Investigational Site - Zitzmannstraße 2
city: Kaiserslautern
country: Germany
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city: Kamp-Lintfort
country: Germany
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city: Köln-Zollstock
country: Germany
facility: Investigational Site
city: Köln
country: Germany
facility: Investigational Site - Hohenstaufenring 59
city: Köln
country: Germany
facility: Investigational Site - Wilhelm-Ewald-Weg 1
city: Köln
country: Germany
facility: Investigational Site - Zeppelinstraße 1
city: Königs Wusterhausen
country: Germany
facility: Investigational Site
city: Königswinter
country: Germany
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city: Lahr
country: Germany
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city: Landau/Isar
country: Germany
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country: Germany
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country: Germany
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city: Norderstedt
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city: Nordhausen
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facility: Investigational Site - August-Bebel-Platz 33-34
city: Nordhausen
country: Germany
facility: Investigational Site - Bahnhofstraße 17
city: Nordhausen
country: Germany
facility: Investigational Site - Bahnhofstraße 8
city: Offenbach am Main
country: Germany
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city: Offenburg
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city: Oldenburg
country: Germany
facility: Investigational Site
city: Porta Westfalica
country: Germany
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city: Potsdam
country: Germany
facility: Investigational Site - Allee nach Sanssouci 7
city: Potsdam
country: Germany
facility: Investigational Site - Großbeerenstraße 301
city: Quakenbrück
country: Germany
facility: Investigational Site
city: Quedlinburg
country: Germany
facility: Investigational Site
city: Recklinghausen
country: Germany
facility: Investigational Site
city: Rendsburg
country: Germany
facility: Investigational Site - Materialhofstraße 9-11
city: Ribnitz-Damgarten
country: Germany
facility: Investigational Site
city: Rinteln
country: Germany
facility: Investigational Site
city: Rostock
country: Germany
facility: Investigational Site
city: Saarbrücken
country: Germany
facility: Investigational Site - Berliner Promenade 15
city: Saarbrücken
country: Germany
facility: Investigational Site - Kaiserslauterer Str. 26
city: Salzgitter
country: Germany
facility: Investigational Site - Heckenstraße 10
city: Salzgitter
country: Germany
facility: Investigational Site - In den Blumentriften 62
city: Salzmünde
country: Germany
facility: Investigational Site
city: Schleswig
country: Germany
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city: Schwerte
country: Germany
facility: Investigational Site - Am Ostentor 5
city: Schwerte
country: Germany
facility: Investigational Site - Karl-Gerharts-Straße 2
city: Seehausen
country: Germany
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city: Solingen
country: Germany
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city: Sömmerda
country: Germany
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city: Taucha
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city: Tostedt
country: Germany
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city: Trier
country: Germany
facility: Investigational Site - Fleischstraße 20
city: Trier
country: Germany
facility: Investigational Site - Kutzbachstraße 7
city: Ulm
country: Germany
facility: Investigational Site - Einsteinstraße 59
city: Ulm
country: Germany
facility: Investigational Site - Olgastraße 103
city: Ulm
country: Germany
facility: Investigational Site - Olgastraße 139
city: Velbert
country: Germany
facility: Investigational Site
city: Wesel
country: Germany
facility: Investigational Site
city: Wilhelmshaven
country: Germany
facility: Investigational Site
city: Witten
country: Germany
facility: Investigational Site
city: Wuppertal
country: Germany
facility: Investigational Site - Langerfelder Straße 115
city: Wuppertal
country: Germany
facility: Investigational Site - Morianstraße 10
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: