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
Results First Received: March 15, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Nocturia Associated With Nocturnal Polyuria
Intervention: Drug: desmopressin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This was a post marketing, non-randomized surveillance study. The 138 participants were screened from 60 German sites.

The study planned for two visits – baseline (week 0 and week 12). Participants could opt for an optional visit between week 0 and week 12 (17 participants did not opt for optional visit).


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Desmopressin 0.1 mg

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

Drug given by prescription.


Participant Flow:   Overall Study
    Desmopressin 0.1 mg  
STARTED     138  
Participants Who Received Treatment     137  
COMPLETED     132  
NOT COMPLETED     6  
Lost to Follow-up Prior to First Visit                 1  
Adverse Event                 2  
Lack of Efficacy                 2  
Protocol Violation                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Desmopressin 0.1 mg

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

Drug given by prescription.


Baseline Measures
    Desmopressin 0.1 mg  
Number of Participants  
[units: participants]
  137  
Age  
[units: years]
Mean ± Standard Deviation
  62.6  ± 7.8  
Gender  
[units: participants]
 
Female     0  
Male     137  
Region of Enrollment  
[units: participants]
 
Germany     137  



  Outcome Measures
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1.  Primary:   Overall Mean Change From Baseline in Mean Number of Nighttime Voids at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Mean Change From Baseline in Ratio of Nighttime Urine Volume to 24-hour Urine Volume at Week 12   [ Time Frame: Baseline, Week 12 ]

3.  Secondary:   Mean Change From Baseline in Initial Period of Undisturbed Sleep at Week 12   [ Time Frame: Baseline, Week 12 ]

4.  Secondary:   Mean Change From Baseline of Total International Prostate Symptom Score (IPSS) at Week 12   [ Time Frame: Baseline, Week 12 ]

5.  Secondary:   Mean Change From Baseline International Prostate Symptom Score (IPSS) Quality of Life Score at Week 12   [ Time Frame: Baseline, Week 12 ]

6.  Secondary:   Mean Change From Baseline in Total Score in Leeds Sleep Evaluation Questionnaire (LSEQ) at Week 12   [ Time Frame: Baseline, Week 12 ]

7.  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)   [ Time Frame: Baseline, Week 12 ]

8.  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   [ Time Frame: Baseline, Week 12 ]

9.  Secondary:   Participants With Treatment Emergent Adverse Events (AEs)   [ Time Frame: Week 1 to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com


No publications provided


Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00902265     History of Changes
Other Study ID Numbers: FE992026 CS33
Study First Received: May 14, 2009
Results First Received: March 15, 2011
Last Updated: April 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices