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

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00902265
First received: May 14, 2009
Last updated: April 15, 2011
Last verified: April 2011

May 14, 2009
April 15, 2011
February 2009
March 2010   (final data collection date for primary outcome measure)
Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
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.
Number of nocturnal voids [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00902265 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).
  • Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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.
  • 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) [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).
  • 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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).
  • Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 1 to Week 12 ] [ Designated as safety issue: Yes ]
  • Ratio of night/24-h urine volume (%) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Duration of first undisturbed sleep period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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).

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

private practices

Nocturia Associated With Nocturnal Polyuria
Drug: desmopressin
desmopressin (Nocturin®) 0.1 mg tablet per day for 12 weeks
Other Name: Nocturin®
desmopressin

Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.

Drug given by prescription.

Intervention: Drug: desmopressin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
138
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications according to Summary of Product Characteristics
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00902265
FE992026 CS33
No
Clinical Development Support, Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP