Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)
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).
1 other identifier
observational
138
1 country
140
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2009
140 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
April 11, 2011
CompletedApril 19, 2011
April 1, 2011
1.1 years
May 14, 2009
March 15, 2011
April 15, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12
The number of nighttime voids was calculated over 48-hours period prior to baseline and week 12 visits. Calculated as Week 12 measure - Baseline measure.
Baseline, Week 12
Secondary Outcomes (8)
Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12
Baseline, Week 12
Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12
Baseline, Week 12
Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12
Baseline, Week 12
Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12
Baseline, Week 12
Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12
Baseline, Week 12
- +3 more secondary outcomes
Study Arms (1)
desmopressin
Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria. Drug given by prescription.
Interventions
desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks
Eligibility Criteria
private practices
You may qualify if:
- Therapeutic need according to Summary of Product Characteristics
- Written informed consent
You may not qualify if:
- Contraindications according to Summary of Product Characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (140)
Investigational Site - Pauwelsstraße 30
Aachen, Germany
Investigational Site - Sanatoriumstraße 10
Aachen, Germany
Investigational Site
Arnsberg, Germany
Investigational Site
Bad Bergzaben, Germany
Investigational Site
Bad Schönborn, Germany
Investigational Site
Baierbrunn, Germany
Investigational Site
Bergisch Gladbach, Germany
Investigational Site - Breite Straße 37
Berlin, Germany
Investigational Site - Britzer Damm 63
Berlin, Germany
Investigational Site - Florastraße 44
Berlin, Germany
Investigational Site - Fritz-Reuter-Straße 6-8
Berlin, Germany
Investigational Site - Heerstraße 435
Berlin, Germany
Investigational Site - Kaiserdamm 12
Berlin, Germany
Investigational Site - Kurfürstendamm 33
Berlin, Germany
Investigational Site - Marburger Straße 12/13
Berlin, Germany
Investigational Site - Mehrower Allee 22
Berlin, Germany
Investigational Site - Rüdesheimer Straße 43
Berlin, Germany
Investigational Site - Schnellerstraße 123
Berlin, Germany
Investigational Site - Tempelhofer Damm 214
Berlin, Germany
Investigational Site - Turmstraße 82
Berlin, Germany
Investigational Site
Biberach, Germany
Investigational Site
Bochum, Germany
Investigational Site
Bonn, Germany
Investigational Site - Friedrich-Wilhelm-Str. 43/44
Braunschweig, Germany
Investigational Site - Güldenstraße 19-20
Braunschweig, Germany
Investigational Site - Humboldtstraße 4
Braunschweig, Germany
Investigational Site - Küchenstraße 10
Braunschweig, Germany
Investigational Site - Ritterbrunnen 7
Braunschweig, Germany
Investigational Site - Dr.-Franz-Mertens-Str. 8
Bremerhaven, Germany
Investigational Site - Georgstraße 44
Bremerhaven, Germany
Investigational Site
Bruchköbel, Germany
Investigational Site
Brühl, Germany
Investigational Site
Butzbach, Germany
Investigational Site
Bückeburg, Germany
Investigational Site
Büdingen, Germany
Investigational Site - Großer Plan 11
Celle, Germany
Investigational Site - Neumarkt 1d
Celle, Germany
Investigational Site - Hohenstaufenring 59
Cologne, Germany
Investigational Site - Wilhelm-Ewald-Weg 1
Cologne, Germany
Investigational Site - Zeppelinstraße 1
Cologne, Germany
Investigational Site
Cottbus, Germany
Investigational Site
Dorsten, Germany
Investigational Site - Hansastraße 14-16
Dortmund, Germany
Investigational Site - Markt 4
Dortmund, Germany
Investigational Site - Wittbräucker Str. 2
Dortmund, Germany
Investigational Site
Düsseldorf, Germany
Investigational Site
Eilenburg, Germany
Investigational Site
Eisenberg, Germany
Investigational Site
Eisleben Lutherstadt, Germany
Investigational Site
Erftstadt, Germany
Investigational Site - Altessener Str. 400a
Essen, Germany
Investigational Site - Gerichtsstraße 32
Essen, Germany
Investigational Site - Humannstraße 3
Essen, Germany
Investigational Site - Rüttenscheider Stern 5
Essen, Germany
Investigational Site - Bologarostraße 131
Frankfurt a.M., Germany
Investigational Site - Eschersheimer Landstr. 544
Frankfurt a.M., Germany
Investigational Site - Oeder Weg 72
Frankfurt a.M., Germany
Investigational Site - Ginnheimer Landstraße 88
Frankfurt am Main, Germany
Investigational Site
Gardelegen, Germany
Investigational Site - Zum Ehrenmal 21
Gelsenkirchen, Germany
Investigational Site
Gera, Germany
Investigational Site
Gifhorn, Germany
Investigational Site
Gotha, Germany
Investigational Site
Grimma, Germany
Investigational Site - Diesterwegstraße 39
Halle, Germany
Investigational Site - Nimeyerstraße 23
Halle, Germany
Investigational Site - Grindelberg 3
Hamburg, Germany
Investigational Site - Möllner Landstraße 27
Hamburg, Germany
Investigational Site
Hanover, Germany
Investigational Site
Hemmoor, Germany
Investigational Site
Homburg, Germany
Investigational Site
Höchheim, Germany
Investigational Site
Hönow, Germany
Investigational Site - Dornburger Straße 17a
Jena, Germany
Investigational Site - Ernst-Abbe-Platz 3-4
Jena, Germany
Investigational Site - Zitzmannstraße 2
Jena, Germany
Investigational Site
Kaiserslautern, Germany
Investigational Site
Kamp-Lintfort, Germany
Investigational Site
Karlsruhe, Germany
Investigational Site
Kiel, Germany
Investigational Site
Kleinmanchow, Germany
Investigational Site
Köln-Zollstock, Germany
Investigational Site
Königs Wusterhausen, Germany
Investigational Site
Königswinter, Germany
Investigational Site
Lahr, Germany
Investigational Site
Landau/Isar, Germany
Investigational Site
Landshut, Germany
Investigational Site
Langenau, Germany
Investigational Site
Lauterbach, Germany
Investigational Site
Leipzig, Germany
Investigational Site
Lindau, Germany
Investigational Site
Magdeburg, Germany
Investigational Site
Marburg, Germany
Investigational Site
Markkleeberg, Germany
Investigational Site
Meschede, Germany
Investigational Site
Nettetal, Germany
Investigational Site
Neunkirchen, Germany
Investigational Site
Nienburg, Germany
Investigational Site
Norderstedt, Germany
Investigational Site - August-Bebel-Platz 33-34
Nordhausen, Germany
Investigational Site - Bahnhofstraße 17
Nordhausen, Germany
Investigational Site - Bahnhofstraße 8
Nordhausen, Germany
Investigational Site
Offenbach, Germany
Investigational Site
Offenburg, Germany
Investigational Site
Oldenburg, Germany
Investigational Site
Porta Westfalica, Germany
Investigational Site - Allee nach Sanssouci 7
Potsdam, Germany
Investigational Site - Großbeerenstraße 301
Potsdam, Germany
Investigational Site
Quakenbrück, Germany
Investigational Site
Quedlinburg, Germany
Investigational Site
Recklinghausen, Germany
Investigational Site - Materialhofstraße 9-11
Rendsburg, Germany
Investigational Site
Ribnitz-Damgarten, Germany
Investigational Site
Rinteln, Germany
Investigational Site
Rostock, Germany
Investigational Site - Berliner Promenade 15
Saarbrücken, Germany
Investigational Site - Kaiserslauterer Str. 26
Saarbrücken, Germany
Investigational Site - Heckenstraße 10
Salzgitter, Germany
Investigational Site - In den Blumentriften 62
Salzgitter, Germany
Investigational Site
Salzmünde, Germany
Investigational Site
Schleswig, Germany
Investigational Site - Am Ostentor 5
Schwerte, Germany
Investigational Site - Karl-Gerharts-Straße 2
Schwerte, Germany
Investigational Site
Seehausen, Germany
Investigational Site
Solingen, Germany
Investigational Site
Sömmerda, Germany
Investigational Site
Taucha, Germany
Investigational Site
Teltow, Germany
Investigational Site
Tostedt, Germany
Investigational Site - Fleischstraße 20
Trier, Germany
Investigational Site - Kutzbachstraße 7
Trier, Germany
Investigational Site - Einsteinstraße 59
Ulm, Germany
Investigational Site - Olgastraße 103
Ulm, Germany
Investigational Site - Olgastraße 139
Ulm, Germany
Investigational Site
Velbert, Germany
Investigational Site
Wesel, Germany
Investigational Site
Wilhelmshaven, Germany
Investigational Site
Witten, Germany
Investigational Site - Langerfelder Straße 115
Wuppertal, Germany
Investigational Site - Morianstraße 10
Wuppertal, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 14, 2009
First Posted
May 15, 2009
Study Start
February 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
April 19, 2011
Results First Posted
April 11, 2011
Record last verified: 2011-04