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Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary (IMPACT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01552343
First Posted: March 13, 2012
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
Results First Submitted: November 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Nocturia
Interventions: Drug: Desmopressin
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 67 subjects were screened and 11 subjects were screening failures: 5 due to signs of renal impairment, 4 did not have >=2 nocturnal voids every night in the 3-day screening period, 1 had uncontrolled diabetes mellitus, and 1 was leaving town for an undetermined period of time.

Reporting Groups
  Description
Placebo Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
Desmopressin Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.

Participant Flow:   Overall Study
    Placebo   Desmopressin
STARTED   29   27 
COMPLETED   29   27 
NOT COMPLETED   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.
No text entered.

Reporting Groups
  Description
Placebo Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
Desmopressin Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
Total Total of all reporting groups

Baseline Measures
   Placebo   Desmopressin   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   27   56 
Age, Customized 
[Units: Participants]
     
< 65 years   11   13   24 
>=65 years   18   14   32 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  48.3%      12  44.4%      26  46.4% 
Male      15  51.7%      15  55.6%      30  53.6% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   25   23   48 
Black/African American   4   2   6 
Asian   0   1   1 
American Indian/Alaska native   0   1   1 
Ethnic Origin 
[Units: Participants]
     
Hispanic or Latino   6   2   8 
Not Hispanic or Latino   23   25   48 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Pearson Correlation Coefficient Between Change From Baseline to Month 1 in Number of Nocturnal Voids and Change From Baseline to Month 1 in Nocturia Impact (NI) Diary Total Score   [ Time Frame: Day 1 (Baseline), Month 1 ]

2.  Primary:   Difference in Mean Change From Baseline to Month 1 in Nocturia Impact (NI) Total Scores and Overall Impact Question for Responders and Non-Responders   [ Time Frame: Day 1 (Baseline), Month 1 ]

3.  Primary:   Cohen's D Effect Size in Responsiveness in the Nocturia Impact (NI) Total Scores and Overall Impact Question as Measured From Baseline (Day 1) to Month 1   [ Time Frame: Day 1 (Baseline), Month 1 ]

4.  Secondary:   Internal Consistency of the Nocturia Impact (NI) Total Score for Each Day NI Diaries Were Completed Assessed as Cronbach's Alpha Values   [ Time Frame: Screening (Day -20 to Day -18), Baseline (Day -2 to Day 1) and Treatment (Day 28 to Day 30) ]

5.  Secondary:   Construct Validity For the Nocturia Impact (NI) Total Scores and Overall Impact Question (Q12) for Participants With High/Low Number of Nocturnal Voids   [ Time Frame: Screening (Day -20), Baseline (Day 1) ]

6.  Secondary:   Change From Baseline to Month 1 on Nocturia Impact (NI) Total Score   [ Time Frame: Baseline (Day -2 to Day 1), Treatment (Day 28-30) ]

7.  Secondary:   Minimum Post-Treatment Serum Sodium Levels   [ Time Frame: Day 1 up to 1 month ]

8.  Secondary:   Summary of Participants With Treatment-Emergent Adverse Events (TEAEs)   [ Time Frame: Day 1 up to 1 month ]


  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
This was a patient reported outcome (PRO) validation study on a highly selective population (responders on active treatment and non-responsers on placebo from CS40/CS41) and not powered to look at efficacy.


  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 of Results:

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01552343     History of Changes
Other Study ID Numbers: 000034
First Submitted: March 5, 2012
First Posted: March 13, 2012
Results First Submitted: November 21, 2016
Results First Posted: May 5, 2017
Last Update Posted: July 11, 2017