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

Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00477490
First received: May 22, 2007
Last updated: September 29, 2015
Last verified: September 2015
Results First Received: June 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Nocturia
Interventions: Drug: desmopressin acetate
Drug: Placebo

  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

Eighty-eight (88) sites were initiated in the United States and Canada, and 81 of these sites screened subjects; 78 sites enrolled and randomized subjects.

A total of 1412 subjects were screened for Part I of the study; 613 subjects were screening failures.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Potential subjects were given a sleep/voiding diary and urine collection device to record the time and volume of each void for 3 consecutive 24-hour periods.

Randomization was stratified by age (<65, ≥65 years) and by the absence/presence of nocturnal polyuria, defined as a ratio of nighttime urine volume/24-hour urine volume ≥33%.


Reporting Groups
  Description
Placebo Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Desmopressin Melt 10 μg Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Desmopressin Melt 25 μg Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Desmopressin Melt 50 μg Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Desmopressin Melt 100 μg Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Placebo to 10 μg Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
Placebo to 25 μg Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
Placebo to 50 μg Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
Placebo to 100 μg Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.

Participant Flow for 2 periods

Period 1:   Part I: 4 Week Efficacy
    Placebo   Desmopressin Melt 10 μg   Desmopressin Melt 25 μg   Desmopressin Melt 50 μg   Desmopressin Melt 100 μg   Placebo to 10 μg   Placebo to 25 μg   Placebo to 50 μg   Placebo to 100 μg
STARTED   160   163   158   158   160   0   0   0   0 
ITT Population   156 [1]   155 [1]   152 [1]   148 [1]   146 [1]   0   0   0   0 
COMPLETED   145   144   148   138   135   0   0   0   0 
NOT COMPLETED   15   19   10   20   25   0   0   0   0 
Adverse Event                1                4                0                5                6                0                0                0                0 
Serum Sodium <= 125mmol/L                1                0                0                5                4                0                0                0                0 
Protocol Violation                2                0                0                0                1                0                0                0                0 
Withdrawal by Subject                6                5                6                4                9                0                0                0                0 
Lost to Follow-up                2                4                1                5                3                0                0                0                0 
Other, not specified                2                4                0                1                1                0                0                0                0 
Not Reported                1                2                3                0                1                0                0                0                0 
[1] Received at least one dose of study drug and provided at least one primary efficacy measure.

Period 2:   Part II: Extension Week 5 up to Day 169
    Placebo   Desmopressin Melt 10 μg   Desmopressin Melt 25 μg   Desmopressin Melt 50 μg   Desmopressin Melt 100 μg   Placebo to 10 μg   Placebo to 25 μg   Placebo to 50 μg   Placebo to 100 μg
STARTED   0   135   135   132   127   31   37   34   34 
COMPLETED   0   107   120   120   107   25   32   29   26 
NOT COMPLETED   0   28   15   12   20   6   5   5   8 
Withdrawal by Subject                0                15                7                7                10                4                2                3                2 
Adverse Event                0                2                3                1                1                1                1                1                4 
Lost to Follow-up                0                3                2                0                5                0                1                0                0 
Decreased sodium                0                0                0                0                1                0                0                1                1 
Excluded medication                0                1                0                0                0                0                0                0                0 
Other, not specified                0                4                2                4                2                1                1                0                1 
Not reported                0                3                1                0                1                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 offered from the Intent-to-Treat population

Reporting Groups
  Description
Placebo Participants took a placebo ‘melt’ for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
Desmopressin Melt 10 μg Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Desmopressin Melt 25 μg Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Desmopressin Melt 50 μg Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Desmopressin Melt 100 μg Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
Total Total of all reporting groups

Baseline Measures
   Placebo   Desmopressin Melt 10 μg   Desmopressin Melt 25 μg   Desmopressin Melt 50 μg   Desmopressin Melt 100 μg   Total 
Overall Participants Analyzed 
[Units: Participants]
 156   155   152   148   146   757 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.1  (13.39)   61.7  (14.41)   62.4  (13.22)   61.6  (11.80)   62.1  (12.34)   62.0  (13.05) 
Gender 
[Units: Participants]
           
Female   66   73   65   71   66   341 
Male   90   82   87   77   80   416 
Race/Ethnicity, Customized 
[Units: Participants]
           
Caucasian   136   123   120   119   111   609 
Black/African American   16   21   28   24   27   116 
Asian   3   2   2   3   6   16 
American Indian/Alaskan Native   0   2   0   0   0   2 
Native Hawaiian/other Pacific Islander   0   1   1   0   0   2 
Other   1   6   1   2   2   12 
Ethnic Origin 
[Units: Participants]
           
Hispanic   13   10   10   13   6   52 
Not Hispanic   143   145   142   135   140   705 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4   [ Time Frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I) ]

2.  Primary:   Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4   [ Time Frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I) ]

3.  Secondary:   Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169   [ Time Frame: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169 ]

4.  Secondary:   Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169   [ Time Frame: - Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169 ]

5.  Secondary:   Part I: Change From Baseline in Total Reported Sleep Time at Week 4   [ Time Frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I) ]

6.  Secondary:   Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4   [ Time Frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I) ]

7.  Secondary:   Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4   [ Time Frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I) ]

8.  Secondary:   Part I: Change From Baseline in the Two Domain Scores of the Nocturia Quality of Life (NQoL) Questionnaire at Week 4   [ Time Frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I) ]

9.  Secondary:   Part I: Change From Baseline in Quality of Sleep as Assessed by the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Week 4   [ Time Frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I) ]

10.  Secondary:   Part I: Change From Baseline in the Mental Health Summary and the Physical Health Summary of the Short Form-12 Version 2 (SF-12v2) at Week 4   [ Time Frame: - Week 3 to Day 1 (Baseline), Week 4 (end of Part I) ]

11.  Secondary:   Part I: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part I   [ Time Frame: Day 1 up to Week 4 (end of Part I) ]

12.  Secondary:   Part II: Participants With Treatment-Emergent Adverse Events (AEs) During Study Part II   [ Time Frame: Week 5 up to Day 169 ]


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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00477490     History of Changes
Other Study ID Numbers: FE992026 CS29
Study First Received: May 22, 2007
Results First Received: June 16, 2015
Last Updated: September 29, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada