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    Summary
    EudraCT Number:2012-004388-34
    Sponsor's Protocol Code Number:000088
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-01-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-004388-34
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated with Desmopressin Orally Disintegrating Tablets as compared to Placebo
    A.3.2Name or abbreviated title of the trial where available
    DAISS
    A.4.1Sponsor's protocol code number000088
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFerring Pharmaceuticals A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFerring Pharmaceuticals A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFerring Pharmaceuticals A/S
    B.5.2Functional name of contact pointClinical Development Support
    B.5.3 Address:
    B.5.3.1Street AddressKay Fiskers Plads 11
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2300
    B.5.3.4CountryDenmark
    B.5.6E-mailDK0-Disclosure@ferring.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDesmopressin orally disintegrating tablet
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESMOPRESSIN
    D.3.9.1CAS number 16679-58-6
    D.3.9.2Current sponsor codeFE 992026
    D.3.9.4EV Substance CodeSUB07001MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDesmopressin orally disintegrating tablet
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESMOPRESSIN
    D.3.9.1CAS number 16679-58-6
    D.3.9.2Current sponsor codeFE 992026
    D.3.9.4EV Substance CodeSUB07001MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral lyophilisate
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nocturia
    E.1.1.1Medical condition in easily understood language
    The complaint that the individual has to wake up at night one or more times to void
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent has been given prior to performance of any trial-related activity

    2. Male or female patients, aged 25-65 years at the time of written consent, who currently have a regular sleep/wake schedule with minimal daytime napping

    3. Nocturia symptoms which have been present for ≥6 months prior to trial entry (patient-reported)

    4. At least 2 nocturnal voids per night as judged by the Investigator during both 3-day diary periods
    5. A nocturia index >1 (nocturnal urine production exceeding maximum voided volume)

    6. A time-in-bed period of between 6.0 and 9.5 hours per night (based on screening diary and actigraphy)

    7. The patient is able to read and understand the informed consent form and understand the trial procedures

    8. Pre- or peri-menopausal women must have a negative pregnancy test and be willing and able to use a reliable method of contraception throughout the trial. In the context of this trial, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: implants, injectables, combined or progesterone only oral contraceptives, sexual abstinence or vasectomised (male patients or partners). Amenorrhea of more than 12 months duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test

    9. Be willing and able to stay at the sleep centre as required by the protocol.
    E.4Principal exclusion criteria
    1. Evidence of severe voiding dysfunction defined as >10 nocturnal voids as documented on any given night in the voiding diary during the screening period

    2. History of, or evidence of obstructive sleep apnoea (AHI >10) and PLMS (≥10 arousals) as measured by PSG at Visit 1b

    3. Evidence of other sleep disorders which are independent of nocturia

    4. Signs or symptoms of any of the following diseases:
    • severe bladder outlet obstruction with a Q max <5 ml/sec as confirmed by uroflowmetry; urinary retention or a post-void residual volume in excess of 150 mL (in women) or 250 mL (in men) as confirmed by bladder ultrasound
    • severe lower urinary tract symptoms (LUTS) as defined by International Prostate Symptom Score (IPSS) (20 to 35 represents severe symptoms)
    • interstitial cystitis
    • moderate to severe overactive bladder (OAB) defined as ≥8 daytime voids per day/night time cycle, and/or any urge urinary incontinence (UUI) episode as documented in the 3-day voiding diary period just before Visit 2 patients with UUI are to be excluded.
    • moderate to severe, as judged by the Investigator, stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on previous history

    5. Genito-urinary tract pathology which in the opinion of the Investigator may be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder related pain, or stone in the bladder and urethra causing symptoms

    6. Urological malignancies

    7. Neurogenic detrusor overactivity (e.g. parkinson, spinal cord damage, etc.)

    8. Central or nephrogenic diabetes insipidus

    9. Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding >40 mL/kg/24 hours)

    10. Syndrome of inappropriate antidiuretic hormone (SIADH)

    11. Cardiac failure, evidence based on physical examination, cardiac medical history, and electrocardiogram (ECG) output

    12. Uncontrolled hypertension

    13. Uncontrolled diabetes mellitus

    14. Hyponatraemia with a serum sodium level <135 mmol/L or history of hyponatraemia

    15. Renal insufficiency: Serum creatinine must be within normal laboratory reference intervals and estimated glomerular filtration rate must be ≥50 mL/min

    16. Known or suspected clinically significant hepatic and/or biliary diseases:
    •aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range (≤2 X ULN) and total bilirubin level must not be more than 1.5 mg/dL
    •if AST and/or ALT ≥2 but ≤3 X ULN, total bilirubin level must be normal
    •if total bilirubin level 1.5-2.0 mg/dL, AST and/or ALT must be normal


    17. Women who are pregnant, breastfeeding, or who plan to become pregnant during the period of the trial
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints

    Nocturia Endpoints:
    • Mean number of nocturnal voids at Month 1 and Month 3
    • Mean time to first void at Month 1 and Month 3.

    Sleep Endpoints:
    • Objective Measures of Sleep – polysomnography (PSG)
    • Objective Measures of Sleep - Actigraphy
    • Subjective Measures of Voiding and Sleep

    Daytime Endpoints:
    • Subjective Measures of Daytime Performance

    Safety Endpoints:
    • Incidence, type and severity of adverse events (AEs)
    • Clinically significant changes in laboratory values, vital signs, and physical examinations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continually throughout the trial
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-06-20
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