Nocturia Associated With Nocturnal Polyuria Clinical Trial
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).
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.
| Status | Completed |
| Enrollment | 138 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Therapeutic need according to Summary of Product Characteristics - Written informed consent Exclusion Criteria: - Contraindications according to Summary of Product Characteristics |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Investigational Site - Pauwelsstraße 30 | Aachen | |
| Germany | Investigational Site - Sanatoriumstraße 10 | Aachen | |
| Germany | Investigational Site | Arnsberg | |
| Germany | Investigational Site | Bad Bergzabern | |
| 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 | Bückeburg | |
| Germany | Investigational Site | Büdingen | |
| Germany | Investigational Site | Butzbach | |
| Germany | Investigational Site - Großer Plan 11 | Celle | |
| Germany | Investigational Site - Neumarkt 1d | Celle | |
| 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 | 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 - Ginnheimer Landstraße 88 | Frankfurt /Main | |
| 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 | 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 | Hannover | |
| Germany | Investigational Site | Hemmoor | |
| Germany | Investigational Site | Hochheim | |
| Germany | Investigational Site | Homburg | |
| 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 - Hohenstaufenring 59 | Köln | |
| Germany | Investigational Site - Wilhelm-Ewald-Weg 1 | Köln | |
| Germany | Investigational Site - Zeppelinstraße 1 | Köln | |
| 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 | Lutherstadt Eisleben | |
| 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 am Main | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Ferring Pharmaceuticals |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 | The ratio of nighttime urine volume to 24-hour urine volume is calculated as the urine volume (volume of all voids after going to bed plus the first morning void) / 24-hour urine volume. Ratios are calculated at baseline and week 12 and difference between the two time points is reported here. | Baseline, Week 12 | No |
| Secondary | Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12 | Initial period of undisturbed sleep is calculated as the number of hours between falling asleep and waking for the first time during the night to void. Change is calculated at Week 12 - baseline. | Baseline, Week 12 | No |
| Secondary | Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12 | The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The first 7 items are summed into a total score and question urination frequency. They are scaled 0-5, with higher numbers indicating greater severity of symptoms. The last question (item 8) concerns QOL and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. The total scale across all questions is 0-41, with higher scores representing worse symptoms. | Baseline, Week 12 | No |
| Secondary | Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12 | The International Prostate Symptoms Score (IPSS) is a self-administered 8 item questionnaire designed to assess urination frequency and Quality of Life (QOL). The last question (item 8) concerns Quality of Life (QOL) and is scaled 0-6 where higher numbers indicate lower quality of life due to symptoms. Higher scores represent worse Quality of Life (QoL). | Baseline, Week 12 | No |
| Secondary | Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12 | The LSEQ is a self-administered 10-item visual analog scale questionnaire designed to assess sleep quality. The 10 individual items are scored 1 to 100, with the total score ranging from 0 - 1,000. Higher numbers indicate lower sleep quality. | Baseline, Week 12 | No |
| Secondary | 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) | The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 1 and 2 participants were asked to estimate the frequency of both daytime voiding (all voids before going to bed excluding the first morning void) and rate the degree of bother of daytime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QoL). | Baseline, Week 12 | No |
| Secondary | 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 | The ICIQ-N is a self-administered 4-item questionnaire designed to assess the frequency and bother of daytime and nighttime urination. In questions 3 and 4, participants were asked to estimate the frequency of nighttime voiding (number of voids after going to bed plus the first morning void) and rate the degree of bother of nighttime urination on a scale ranging from 0 (not at all) to 10 (a great deal). Higher numbers indicate lower Quality of Life (QOL). | Baseline, Week 12 | No |
| Secondary | Participants With Treatment Emergent Adverse Events (AEs) | Week 1 to Week 12 | Yes |