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    Clinical Trial Results:
    A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated with Desmopressin Orally Disintegrating Tablets as compared to Placebo.

    Summary
    EudraCT number
    2012-004388-34
    Trial protocol
    GB  
    Global end of trial date
    01 Jun 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Mar 2016
    First version publication date
    18 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    000088
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01779466
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Ferring Pharmaceuticals A/S
    Sponsor organisation address
    Kay Fiskers Plads 11, Copenhagen S, Denmark, 2300
    Public contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Scientific contact
    Clinical Development Support, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    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
    08 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Efficacy Objectives • To investigate the relationship between nocturia, sleep, and daytime performance • To investigate the efficacy of desmopressin orally disintegrating tablets (50 µg in men and 25 µg in women) versus placebo for treatment of patients with nocturia with respect to nocturia, sleep, and daytime performance. Safety Objective • To confirm the safety of desmopressin orally disintegrating tablets (50 µg in men and 25 µg in women) in the treatment of nocturia.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial including the possibility to discontinue at any time in language and terms appropriate for the patient and considering the local culture. Collected personal data and human biological samples were processed in compliance with the Declaration of Helsinki and its amendments in force at the initiation of the trial in compliance with the approved protocol and its amendments, Good Clinical Practice (GCP) and applicable regulatory requirements. For safety reasons, serum sodium levels were monitored at regular intervals and a patient was to be withdrawn from the trial if the serum sodium level was ≤125 mmol/L or had any other sign of fluid overload such as peripheral or pulmonary oedema at any time point during the trial.
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    09 Apr 2013
    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
    United Kingdom: 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

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in United Kingdom between 09 Apr 2013 to 01 Jun 2014. Screening was stopped on 26 Feb 2014 due to poor recruitment. At that time, only five female subjects had been randomised.

    Pre-assignment
    Screening details
    The intent was to randomise eligible subjects to one of the three treatments: Placebo, Desmopressin 50 µg (for men), and Desmopressin 25 µg (for females). However, only five female subjects (three in Desmopressin 25 µg, two in Placebo) and no male subjects (Desmopressin 50 µg) could be enrolled in the trial.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor
    Blinding implementation details
    Treatment was blinded throughout. Both active and placebo IMP were provided as round, white tablets, marked with a diamond shaped figure on one side.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Desmopressin 25 μg orally disintegrating tablets
    Arm description
    Desmopressin 25 μg orally disintegrating tablets for sublingual administration in the strength of 25 μg – for women only
    Arm type
    Experimental

    Investigational medicinal product name
    Desmopressin 25 μg
    Investigational medicinal product code
    FE 992026
    Other name
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Subjects had to take one orally disintegrating tablet each night, approximately one hour prior to bedtime, for the entire duration of the three-month treatment period. Patients were instructed to place the tablet under the tongue and not to chew or swallow the table. They were also advised to minimise fluid intake from two hours before bedtime until seven hours after.

    Arm title
    Placebo
    Arm description
    Placebo (not active) orally disintegrating tablets for sublingual administration – for both men and women.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sublingual tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    Patients had to take one orally disintegrating tablet each night, approximately one hour prior to bedtime, for the entire duration of the three-month treatment period. Patients were instructed to place the tablet under the tongue and not to chew or swallow the table. They were also advised to minimise fluid intake from two hours before bedtime until seven hours after.

    Number of subjects in period 1
    Desmopressin 25 μg orally disintegrating tablets Placebo
    Started
    3
    2
    Completed
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    5 5
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    5 5
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    5 5
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Desmopressin 25 μg orally disintegrating tablets
    Reporting group description
    Desmopressin 25 μg orally disintegrating tablets for sublingual administration in the strength of 25 μg – for women only

    Reporting group title
    Placebo
    Reporting group description
    Placebo (not active) orally disintegrating tablets for sublingual administration – for both men and women.

    Primary: Efficacy Endpoints

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    End point title
    Efficacy Endpoints [1]
    End point description
    There was no efficacy evaluation.
    End point type
    Primary
    End point timeframe
    There was no efficacy evaluation.
    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 efficacy objectives/endpoints were analysed due to low number of subjects.
    End point values
    Desmopressin 25 μg orally disintegrating tablets Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: Nocturia/Sleep/Daytime endpoints
    Notes
    [2] - Efficacy not evaluated since only five females were enrolled.
    [3] - Efficacy not evaluated since only five females were enrolled.
    No statistical analyses for this end point

    Primary: Clinically significant laboratory results

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    End point title
    Clinically significant laboratory results [4]
    End point description
    Safety laboratory variables included clinical chemistry, haematology and urinalysis. The Investigator reviewed the laboratory results and documented whether the results were normal or abnormal, and whether results were clinically or not clinically significant.
    End point type
    Primary
    End point timeframe
    Blood and urine samples for the assessment of safety laboratory variables were taken at Visit 0 (Screening) and Visit 5, Day 3. An additional blood sample for the analysis and monitoring of serum sodium were taken at Visit 3.
    Notes
    [4] - 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: The safety assessments were only presented as patient data listings i.e., no statistical analyses was performed as only five female subjects were enrolled in the trial.
    End point values
    Desmopressin 25 μg orally disintegrating tablets Placebo
    Number of subjects analysed
    3
    2
    Units: Number of subjects
    0
    0
    No statistical analyses for this end point

    Primary: Clinically significant vital signs and physical examinations

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    End point title
    Clinically significant vital signs and physical examinations [5]
    End point description
    Vitals: Diastolic and systolic blood pressure (mmHg) and pulse (beats per minute) were measured after resting for 5 minutes in a sitting position. Vital signs measurements outside normal ranges were to be assessed as “abnormal, not clinically significant” or “abnormal, clinically significant” by the Investigator. Any abnormal, clinically significant changes were to be reported as adverse events (AEs). Physical examinations: Physical examinations were performed by the Investigator or a delegated medically licensed qualified Sub-investigator. Any abnormal, clinically significant changes was to be reported as AEs.
    End point type
    Primary
    End point timeframe
    Vitals (Blood pressure and pulse rate): Visit 0, each day of Visits 2, 3, 4 and 5. Physical examinations:Visit 0 and Visit 5; Day 3.
    Notes
    [5] - 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: The safety assessments were only presented as patient data listings i.e., no statistical analyses was performed as only five female subjects were enrolled in the trial.
    End point values
    Desmopressin 25 μg orally disintegrating tablets Placebo
    Number of subjects analysed
    3
    2
    Units: Number of subjects
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The Investigator monitored the condition of the patient throughout the trial from the time of obtaining informed consent until the last visit.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Desmopressin 25 μg orally disintegrating tablets
    Reporting group description
    AEs are presented by-subject for one of the three subjects dosed with Desmopressin 25 μg orally disintegrating tablets.

    Reporting group title
    Placebo
    Reporting group description
    AEs are presented by-subject for one of the two subjects dosed with placebo orally disintegrating tablets.

    Serious adverse events
    Desmopressin 25 μg orally disintegrating tablets Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Desmopressin 25 μg orally disintegrating tablets Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 2 (100.00%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 3 (66.67%)
    2 / 2 (100.00%)
         occurrences all number
    5
    8
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 2 (100.00%)
         occurrences all number
    0
    2
    Thirst
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Skin irritation
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    Pruritus
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Sep 2013
    Inclusion criteria updated to: •Male or female patients, aged 25-65 years (in place of 35-65 years) at the time of written consent, who currently had a regular sleep/wake schedule with minimal daytime napping (in place of a regular daytime schedule) •At least 2 nocturnal voids per night as judged by the Investigator during both 3-day diary periods •A habitual time-in-bed period, attempting to sleep, of between 6.0 and 9.5 hours per night (based on screening diary [CSD] and actigraphy) The exclusion criteria regarding stress incontinence was updated to only moderate or severe cases, as judged by the Investigator.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    20 Feb 2014
    Due to poor recruitment the recruitment of patients in this trial was stopped on 20th of Feb 2014, with only five female patients randomised.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The trial also included a third arm Desmopressin 50 µg orally disintegrating tablets for sublingual administration, for men only. However, no subjects could be enrolled in the arm, hence the details are not presented.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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