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Nocturia Associated With Nocturnal PolyuriaNCT00902265

Efficacy and Safety of Desmopressin (Nocturin®) 0.1 mg Tablets in Treatment of Nocturia in Participants With Benign Prostate Syndrome (BPS)

An observational study of Nocturia Associated With Nocturnal Polyuria, run by Ferring Pharmaceuticals at 140 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years, men only
What is being tested?
desmopressin
Type of treatment
Pill or oral medicine
How many people
138 participants
Where
140 sitesGermany
Study dates
Feb 2009to Mar 2010
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: private practices

Who may be able to join

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

Who cannot join

  • Contraindications according to Summary of Product Characteristics

Trial locations and contacts

140 sites in 1 country.

140 sites in 1 country

Germany140 sites

  • Investigational Site - Pauwelsstraße 30

    Aachen

  • Investigational Site - Sanatoriumstraße 10

    Aachen

  • Investigational Site

    Arnsberg

  • Investigational Site

    Bad Bergzaben

  • Investigational Site

    Bad Schönborn

  • Investigational Site

    Baierbrunn

  • Investigational Site

    Bergisch Gladbach

  • Investigational Site - Breite Straße 37

    Berlin

  • Investigational Site - Britzer Damm 63

    Berlin

  • Investigational Site - Florastraße 44

    Berlin

  • Investigational Site - Fritz-Reuter-Straße 6-8

    Berlin

  • Investigational Site - Heerstraße 435

    Berlin

  • Investigational Site - Kaiserdamm 12

    Berlin

  • Investigational Site - Kurfürstendamm 33

    Berlin

  • Investigational Site - Marburger Straße 12/13

    Berlin

  • Investigational Site - Mehrower Allee 22

    Berlin

  • Investigational Site - Rüdesheimer Straße 43

    Berlin

  • Investigational Site - Schnellerstraße 123

    Berlin

  • Investigational Site - Tempelhofer Damm 214

    Berlin

  • Investigational Site - Turmstraße 82

    Berlin

  • Investigational Site

    Biberach

  • Investigational Site

    Bochum

  • Investigational Site

    Bonn

  • Investigational Site - Friedrich-Wilhelm-Str. 43/44

    Braunschweig

  • Investigational Site - Güldenstraße 19-20

    Braunschweig

  • Investigational Site - Humboldtstraße 4

    Braunschweig

  • Investigational Site - Küchenstraße 10

    Braunschweig

  • Investigational Site - Ritterbrunnen 7

    Braunschweig

  • Investigational Site - Dr.-Franz-Mertens-Str. 8

    Bremerhaven

  • Investigational Site - Georgstraße 44

    Bremerhaven

  • Investigational Site

    Bruchköbel

  • Investigational Site

    Brühl

  • Investigational Site

    Bückeburg

  • Investigational Site

    Büdingen

  • Investigational Site

    Butzbach

  • Investigational Site - Großer Plan 11

    Celle

  • Investigational Site - Neumarkt 1d

    Celle

  • Investigational Site - Hohenstaufenring 59

    Cologne

  • Investigational Site - Wilhelm-Ewald-Weg 1

    Cologne

  • Investigational Site - Zeppelinstraße 1

    Cologne

  • Investigational Site

    Cottbus

  • Investigational Site

    Dorsten

  • Investigational Site - Hansastraße 14-16

    Dortmund

  • Investigational Site - Markt 4

    Dortmund

  • Investigational Site - Wittbräucker Str. 2

    Dortmund

  • Investigational Site

    Düsseldorf

  • Investigational Site

    Eilenburg

  • Investigational Site

    Eisenberg

  • Investigational Site

    Eisleben Lutherstadt

  • Investigational Site

    Erftstadt

  • Investigational Site - Altessener Str. 400a

    Essen

  • Investigational Site - Gerichtsstraße 32

    Essen

  • Investigational Site - Humannstraße 3

    Essen

  • Investigational Site - Rüttenscheider Stern 5

    Essen

  • Investigational Site - Bologarostraße 131

    Frankfurt a.M.

  • Investigational Site - Eschersheimer Landstr. 544

    Frankfurt a.M.

  • Investigational Site - Oeder Weg 72

    Frankfurt a.M.

  • Investigational Site - Ginnheimer Landstraße 88

    Frankfurt am Main

  • Investigational Site

    Gardelegen

  • Investigational Site - Zum Ehrenmal 21

    Gelsenkirchen

  • Investigational Site

    Gera

  • Investigational Site

    Gifhorn

  • Investigational Site

    Gotha

  • Investigational Site

    Grimma

  • Investigational Site - Diesterwegstraße 39

    Halle

  • Investigational Site - Nimeyerstraße 23

    Halle

  • Investigational Site - Grindelberg 3

    Hamburg

  • Investigational Site - Möllner Landstraße 27

    Hamburg

  • Investigational Site

    Hanover

  • Investigational Site

    Hemmoor

  • Investigational Site

    Höchheim

  • Investigational Site

    Homburg

  • Investigational Site

    Hönow

  • Investigational Site - Dornburger Straße 17a

    Jena

  • Investigational Site - Ernst-Abbe-Platz 3-4

    Jena

  • Investigational Site - Zitzmannstraße 2

    Jena

  • Investigational Site

    Kaiserslautern

  • Investigational Site

    Kamp-Lintfort

  • Investigational Site

    Karlsruhe

  • Investigational Site

    Kiel

  • Investigational Site

    Kleinmanchow

  • Investigational Site

    Köln-Zollstock

  • Investigational Site

    Königs Wusterhausen

  • Investigational Site

    Königswinter

  • Investigational Site

    Lahr

  • Investigational Site

    Landau/Isar

  • Investigational Site

    Landshut

  • Investigational Site

    Langenau

  • Investigational Site

    Lauterbach

  • Investigational Site

    Leipzig

  • Investigational Site

    Lindau

  • Investigational Site

    Magdeburg

  • Investigational Site

    Marburg

  • Investigational Site

    Markkleeberg

  • Investigational Site

    Meschede

  • Investigational Site

    Nettetal

  • Investigational Site

    Neunkirchen

  • Investigational Site

    Nienburg

  • Investigational Site

    Norderstedt

  • Investigational Site - August-Bebel-Platz 33-34

    Nordhausen

  • Investigational Site - Bahnhofstraße 17

    Nordhausen

  • Investigational Site - Bahnhofstraße 8

    Nordhausen

  • Investigational Site

    Offenbach

  • Investigational Site

    Offenburg

  • Investigational Site

    Oldenburg

  • Investigational Site

    Porta Westfalica

  • Investigational Site - Allee nach Sanssouci 7

    Potsdam

  • Investigational Site - Großbeerenstraße 301

    Potsdam

  • Investigational Site

    Quakenbrück

  • Investigational Site

    Quedlinburg

  • Investigational Site

    Recklinghausen

  • Investigational Site - Materialhofstraße 9-11

    Rendsburg

  • Investigational Site

    Ribnitz-Damgarten

  • Investigational Site

    Rinteln

  • Investigational Site

    Rostock

  • Investigational Site - Berliner Promenade 15

    Saarbrücken

  • Investigational Site - Kaiserslauterer Str. 26

    Saarbrücken

  • Investigational Site - Heckenstraße 10

    Salzgitter

  • Investigational Site - In den Blumentriften 62

    Salzgitter

  • Investigational Site

    Salzmünde

  • Investigational Site

    Schleswig

  • Investigational Site - Am Ostentor 5

    Schwerte

  • Investigational Site - Karl-Gerharts-Straße 2

    Schwerte

  • Investigational Site

    Seehausen

  • Investigational Site

    Solingen

  • Investigational Site

    Sömmerda

  • Investigational Site

    Taucha

  • Investigational Site

    Teltow

  • Investigational Site

    Tostedt

  • Investigational Site - Fleischstraße 20

    Trier

  • Investigational Site - Kutzbachstraße 7

    Trier

  • Investigational Site - Einsteinstraße 59

    Ulm

  • Investigational Site - Olgastraße 103

    Ulm

  • Investigational Site - Olgastraße 139

    Ulm

  • Investigational Site

    Velbert

  • Investigational Site

    Wesel

  • Investigational Site

    Wilhelmshaven

  • Investigational Site

    Witten

  • Investigational Site - Langerfelder Straße 115

    Wuppertal

  • Investigational Site - Morianstraße 10

    Wuppertal

Other trials in Germany

About this study

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.

Being tested
desmopressin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • desmopressinDrug

    Also called Nocturin®

    desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks

Study groups in NCT00902265
Study groupRoleWhat they receive
desmopressinParticipants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria. Drug given by prescription.
Receives: Drug: desmopressin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 12

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, Week 12

  2. 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.

    Measured: Baseline, Week 12

  3. 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.

    Measured: Baseline, Week 12

  4. 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).

    Measured: Baseline, Week 12

  5. 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.

    Measured: Baseline, Week 12

  6. 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).

    Measured: Baseline, Week 12

  7. 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).

    Measured: Baseline, Week 12

  8. Participants With Treatment Emergent Adverse Events (AEs)

    Measured: Week 1 to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00902265
Sponsor's protocol ID
FE992026 CS33
Status last verified
Apr 2011
First submitted
14 May 2009
Last updated
19 Apr 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Nocturia Associated With Nocturnal Polyuria, run by Ferring Pharmaceuticals at 140 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00902265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.

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