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An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00615836
First received: January 18, 2008
Last updated: November 11, 2015
Last verified: November 2015
Results First Received: June 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Nocturia
Intervention: Drug: Desmopressin Melt

  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
The study was open only to participants who were enrolled in Study FE992026 CS29 (NCT00477490) and had completed at least Visit 3E in Part II (Day 15) of that study. 799 patients were randomized to treatment in CS29, and 601 patients formed the intent-to-treat population in CS29. This population was used to assess durability of effect in CS31.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were initially assigned in a blinded manner to the same treatment dose received in Study CS29. After CS29 database lock, CS31 was unblinded, and based on the results of CS29, participants assigned to 10 μg were randomly assigned at their next scheduled visit to 25 μg, 50 μg, or 100 μg of desmopressin Melt.

Reporting Groups
  Description
Desmopressin Melt 10 μg

Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31.

During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).

Desmopressin Melt 25 μg Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
Desmopressin Melt 50 μg Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
Desmopressin Melt 100 μg Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
Placebo Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.

Participant Flow for 2 periods

Period 1:   Part I of Core Study (FE992026 CS29)
    Desmopressin Melt 10 μg   Desmopressin Melt 25 μg   Desmopressin Melt 50 μg   Desmopressin Melt 100 μg   Placebo
STARTED   163   158   158   160   160 
Intent-to-treat Population   155 [1]   152 [1]   148 [1]   146 [1]   156 [1] 
COMPLETED   144   148   138   135   145 
NOT COMPLETED   19   10   20   25   15 
[1] Received at least 1 dose of study drug and provided at least 1 primary efficacy measure.

Period 2:   Extension Study (FE992026 CS31)
    Desmopressin Melt 10 μg   Desmopressin Melt 25 μg   Desmopressin Melt 50 μg   Desmopressin Melt 100 μg   Placebo
STARTED   141   144   132   137   0 
COMPLETED   0   58   59   53   0 
NOT COMPLETED   141   86   73   84   0 
Adverse Event                7                12                15                13                0 
Serum sodium ≤125 mmol/L                1                0                3                3                0 
Use of exclusionary medication                1                2                1                0                0 
Protocol Violation                4                5                2                3                0 
Withdrawal by Subject                37                42                38                43                0 
Lost to Follow-up                10                14                5                10                0 
Not specified                10                7                8                8                0 
Not reported                6                4                1                4                0 
Re-randomized to a higher dose                65                0                0                0                0 



  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.
Demographic data provided for the Efficacy Analysis Dataset, which consisted of the intent-to-treat population from CS29 (all randomized patients who received at least 1 dose of study drug and provided at least 1 primary efficacy measure during Part I) who were on active treatment (i.e., placebo participants are not included).

Reporting Groups
  Description
Desmopressin Melt 10 μg Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
Desmopressin Melt 25 μg Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
Desmopressin Melt 50 μg Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
Desmopressin Melt 100 μg Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
Total Total of all reporting groups

Baseline Measures
   Desmopressin Melt 10 μg   Desmopressin Melt 25 μg   Desmopressin Melt 50 μg   Desmopressin Melt 100 μg   Total 
Overall Participants Analyzed 
[Units: Participants]
 155   152   148   146   601 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.7  (14.41)   62.4  (13.22)   61.6  (11.80)   62.1  (12.34)   61.9  (12.97) 
Age, Customized 
[Units: Participants]
         
<65 years   80   65   71   66   282 
>=65 years   75   87   77   80   319 
Gender 
[Units: Participants]
         
Female   73   65   71   66   275 
Male   82   87   77   80   326 
Race/Ethnicity, Customized 
[Units: Participants]
         
Caucasian   123   120   119   111   473 
Black/African American   21   28   24   27   100 
Asian   2   2   3   6   13 
American Indian/Alaskan Native   2   0   0   0   2 
Native Hawaiian/other Pacific Islander   1   1   0   0   2 
Other   6   1   2   2   11 
Ethnic Origin 
[Units: Participants]
         
Hispanic   10   10   13   6   39 
Not Hispanic   145   142   135   140   562 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Mean Number of Nocturnal Voids   [ Time Frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96. ]

2.  Primary:   Percentage of Participants With a Greater Than 33% Reduction in the Mean Number of Nocturnal Voids   [ Time Frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96. ]

3.  Primary:   Change From Baseline in Initial Period of Undisturbed Sleep   [ Time Frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96. ]

4.  Secondary:   Change From Baseline in Total Sleep Time   [ Time Frame: Baseline of Study CS29 and Weeks 8, 12, 20, 28, 52-56, 72-76, and 92-96. ]

5.  Secondary:   Change From Baseline in International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) Nighttime Urination Bother Score   [ Time Frame: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months) ]

6.  Secondary:   Change From Baseline in Nocturia Quality of Life (NQoL) Overall Score   [ Time Frame: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months) ]

7.  Secondary:   Change From Baseline in NQoL Bother/Concern Domain Score   [ Time Frame: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months) ]

8.  Secondary:   Change From Baseline in Nocturia Quality of Life (NQoL) Sleep/Energy Domain Score   [ Time Frame: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months) ]

9.  Secondary:   Change From Baseline in the Nocturia Quality of Life (NQoL) Global Quality of Life Score   [ Time Frame: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months) ]

10.  Secondary:   Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Global Score   [ Time Frame: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months) ]

11.  Secondary:   Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Mental Component Summary Score   [ Time Frame: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months) ]

12.  Secondary:   Change From Baseline in the Short Form-12, Version 2 (SF-12v2) Physical Component Summary Score   [ Time Frame: Baseline of Study CS29, Week 16, Visit 12 (approximately 56-78 weeks total study time) and End of Study (up to a maximum of 35 months) ]

13.  Secondary:   Participants With Treatment-Emergent Adverse Events (AEs)   [ Time Frame: From first dose of study drug in Study CS29 until the end of study CS31 (up to 35 months). ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00615836     History of Changes
Other Study ID Numbers: FE992026 CS31
Study First Received: January 18, 2008
Results First Received: June 23, 2015
Last Updated: November 11, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada