Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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