Clinical Trial Results:
Desmopressin melt therapy in nocturnal polyuria patients: pharmacodynamic study
Summary
|
|
EudraCT number |
2011-004560-29 |
Trial protocol |
BE |
Global end of trial date |
01 Feb 2013
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
29 Jul 2021
|
First version publication date |
29 Jul 2021
|
Other versions |
|
Summary report(s) |
Statement of discontinuation |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
AGO/2011/010
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
Ghent University Hospital
|
||
Sponsor organisation address |
Corneel Heymanslaan 10, Ghent, Belgium, 9000
|
||
Public contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
|
||
Scientific contact |
Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
01 Feb 2013
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
01 Feb 2013
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
01 Feb 2013
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To determine the pharmacodynamic (PD) characteristics of desmopressin melt in nocturia patients
|
||
Protection of trial subjects |
Ethics review and approval, informed consent, supportive care and routine monitoring.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
19 Mar 2012
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Belgium: 5
|
||
Worldwide total number of subjects |
5
|
||
EEA total number of subjects |
5
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
5
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
||||||||||||||||||||||
Recruitment
|
||||||||||||||||||||||
Recruitment details |
5 patients were screened in the period from 19-03-2012 till 1-02-2013 5 patients were included. 5 patients were randomised. 1 patient was included and completed the trial. End of trial notification was dated 1-02-2013. | |||||||||||||||||||||
Pre-assignment
|
||||||||||||||||||||||
Screening details |
Inclusion criteria: - Written informed consent prior to the performance of any study-related activity - Patients 18 years and older with an average of ≥ 2 nocturnal voids per night - Evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart - Diuresis < 2,5L | |||||||||||||||||||||
Period 1
|
||||||||||||||||||||||
Period 1 title |
Overall Trial (overall period)
|
|||||||||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Not applicable
|
|||||||||||||||||||||
Blinding used |
Not blinded | |||||||||||||||||||||
Arms
|
||||||||||||||||||||||
Are arms mutually exclusive |
No
|
|||||||||||||||||||||
Arm title
|
Baseline arm | |||||||||||||||||||||
Arm description |
Baseline data for the study, as the study only has 1 arm. | |||||||||||||||||||||
Arm type |
Baseline arm | |||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
|
|||||||||||||||||||||
Arm title
|
Treatment arm | |||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Minirin Melt 60 μg
|
|||||||||||||||||||||
Investigational medicinal product code |
CAS 62357-86-2
|
|||||||||||||||||||||
Other name |
||||||||||||||||||||||
Pharmaceutical forms |
Oral lyophilisate
|
|||||||||||||||||||||
Routes of administration |
Sublingual use
|
|||||||||||||||||||||
Dosage and administration details |
the patient has to take Minirin Melt 60 µg in the evening before going to bed instead of Minirin Melt 120 µg.
To reduce the risks, the start dose for this study will be 60 µg Minirin Melt instead of 120 µg. If the effect with desmopressin melt 60 µg is insufficient, the dosis can be increased to 120 µg.
|
|||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Baseline arm
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Baseline data for the study, as the study only has 1 arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment arm
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Baseline arm
|
||
Reporting group description |
Baseline data for the study, as the study only has 1 arm. | ||
Reporting group title |
Treatment arm
|
||
Reporting group description |
- |
|
|||||||||||||
End point title |
Urine production [1] | ||||||||||||
End point description |
|||||||||||||
End point type |
Primary
|
||||||||||||
End point timeframe |
Everyday during the first fourteen days.
|
||||||||||||
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis available. |
|||||||||||||
|
|||||||||||||
Notes [2] - Baseline data for the study, as the study only has 1 arm. |
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Blood analysis for safety profile | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
On day 3, 7 and 30 after the start of the treatment with desmopressin melt
|
||||||||||||
|
|||||||||||||
Notes [3] - Baseline data for the study, as the study only has 1 arm. |
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||
Timeframe for reporting adverse events |
Overall study
|
|||||||||||||||||||||
Assessment type |
Non-systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
14
|
|||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||
Reporting group title |
Baseline arm
|
|||||||||||||||||||||
Reporting group description |
Baseline data for the study, as the study only has 1 arm. | |||||||||||||||||||||
Reporting group title |
Treatment arm
|
|||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||
|
||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
22 Mar 2012 |
Reasons for the substantial amendment: Changes in safety or integrity of trial subjects, changes in interpretation of scientific documents/value of the trial, changes in quality of IMP(s), changes in conduct or management of the trial
DESCRIPTION OF EACH SUBSTANTIAL AMENDMENT:
- the patient has to take Minirin Melt 60 µg in the evening before going to bed instead of Minirin Melt 120 µg.
To reduce the risks, the start dose for this study will be 60 µg Minirin Melt instead of 120 µg. If the effect with desmopressin melt 60 µg is insufficient, the dosis can be increased to 120 µg.
-Addition of 2 new inclusion criteria
(1) evidence for nocturnal polyuria (nocturnal urine volume >33% of total volume over 24h), determined on frequency/volume chart
(2) diuresis <2,5L
-Addition of 1 exclusion criterium and change in 1 of the exclusion criteria
previous wording: moderate to severe renal insufficiency (creatinin clearance < 50 60 ml/min)
new wording: suspicion or evidence of liver failure and moderate to severe renal insufficiency (creatinin clearance < 60 ml/min)
|
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
The trial was early terminated due to a low inclusion rate. |