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    Summary
    EudraCT Number:2017-000808-22
    Sponsor's Protocol Code Number:000278
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-27
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2017-000808-22
    A.3Full title of the trial
    An Open-label Trial Investigating the Association Between Nocturia and Sleep During 12 Weeks of Treatment with Desmopressin Orally Disintegrating Tablet (ODT) for Nocturia due to Nocturnal Polyuria in Adults
    Een open-label onderzoek naar de relatie tussen nycturie en slaap tijdens een behandeling van 12 weken met een desmopressine oraal desintegrerende tablet (ODT) voor nycturie als gevolg van nachtelijke polyurie bij volwassenen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial Investigating the Association Between Nocturia and Sleep
    During 12 Weeks of Treatment with Desmopressin for Nocturia due to Nocturnal Polyuria in Adults
    Een studie over de relaties tussen Nocturia en slaap gedurende een behandeling van 12 weken met Desmopressin voor Nocturia als gevolg van Nocturnal Polyuria bij volwassenen
    A.3.2Name or abbreviated title of the trial where available
    AWAKEN
    AWAKEN
    A.4.1Sponsor's protocol code number000278
    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 Yes
    D.2.1.1.1Trade name NOCDURNA
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Lægemidler A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNocdurna 50 microgram oral lyophilisate
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESMOPRESSIN ACETATE
    D.3.9.1CAS number 62357-86-2
    D.3.9.4EV Substance CodeSUB01597MIG
    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 Yes
    D.2.1.1.1Trade name NOCDURNA
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Lægemidler A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameNocdurna 25 microgram oral lyophilisate
    D.3.4Pharmaceutical form Oral lyophilisate
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESMOPRESSIN ACETATE
    D.3.9.1CAS number 62357-86-2
    D.3.9.4EV Substance CodeSUB01597MIG
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Nocturia due to Nocturnal Polyuria
    E.1.1.1Medical condition in easily understood language
    Frequent nocturnal voiding
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064016
    E.1.2Term Nocturnal polyuria
    E.1.2System Organ Class 100000017861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the association between changes in the number of nocturnal voids and change in Nocturia Sleep Quality Scale (NSQS) total score in adult subjects with nocturia due to Nocturnal Polyuria (NP)
    E.2.2Secondary objectives of the trial
    - To assess the association between changes in Patient Global Impression of Severity (PGI-S) and change in Nocturia Sleep Quality Scale (NSQS) total score
    - To assess the association between Patient Global Impression of Improvement (PGI-I) and change in NSQS total score
    - To assess the association between change in First Undisturbed Sleep Period (FUSP) and change in NSQS total score
    - To assess changes from baseline in NSQS total score
    - To assess changes from baseline in PGI-S and Bother scales
    - To assess PGI-I scores
    - To assess changes from baseline in number of nocturnal voids
    - To assess changes from baseline in FUSP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent prior to performance of any trial-related activity
    2. Adults ≥18 years of age (at the time of written consent)
    3. Female subjects of child-bearing potential must be willing and able to use adequate contraception throughout the trial. Documentation of an acceptable effective method of contraception must be available. All pre- and perimenopausal subjects have to perform pregnancy tests. 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 any pregnancy test
    4. Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
    5. ≥2 nocturnal voids per night (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
    6. The largest single voided volume must be >250 mL (at least 1 void >250 mL) as documented in the 3-day e-Diary prior to Visit 2
    7. Nocturnal polyuria, defined as NPi >33%, a ratio of Nocturnal Urine Volume (NUV) in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
    8. Bothered by nocturia as defined by an NI Diary Total Score of ≥10 points (raw score) as documented in the 3-day e-Diary prior to Visit 2
    E.4Principal exclusion criteria
    1. Current diagnosis of Obstructive Sleep Apnoea (OSA). In case of no current diagnosis of OSA, high-risk subjects should be excluded as assessed by the STOP-Bang questionnaire at Visit 1
    2. Restless Legs Syndrome (RLS)
    3. Current mild to severe depression as assessed by a score of ≥14 on the Beck Depression Inventory-II (BDI-II) scale at Visit 1 or Visit 2
    4. History or suspicion of moderate to severe Lower Urinary Tract Symptoms (LUTS) with or without Bladder Outlet Obstruction (BOO). In case of suspicion of moderate or severe LUTS with or without BOO, subjects should be excluded from the trial as follows:
    - All subjects with a Post-void Residual (PVR) >150 mL, as confirmed by ultrasound during screening prior to Visit 2
    - Male subjects who have International Prostate Symptom Score (IPSS) ≥13 points and urinary flow <5 mL/s, as confirmed by uroflowmetry during screening prior to Visit 2
    5. Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
    6. Predominant daytime voiding dysfunction due to Overactive Bladder (OAB), at Visit 2, defined as:
    Frequency (an average of >8 daytime voids per day during the 3-day diary period)
    AND
    ≥1 daily urgency episode (the subject could not postpone voiding or the subject leaked before arriving to the toilet)
    7. Any pelvic or lower urinary tract surgery and/or radiotherapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for BOO or Benign Prostatic Hyperplasia (BPH), hysterectomy or female incontinence procedures
    8. Genito-urinary tract pathology that can in the investigator’s opinion 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 or urethra causing symptoms
    9. A history of cancer with the last date of disease activity/prescence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
    10. History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson’s, spinal cord injury, spina bifida)
    11. Habitual (fluid intake >3L per day) or psychogenic polydipsia
    12. Uncontrolled hypertension, as judged by the investigator
    13. Uncontrolled diabetes mellitus, as judged by the investigator
    14. Central or nephrogenic diabetes insipidus
    15. Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
    16. History of gastric retention
    17. Known or suspected cardiac insufficiency or other conditions associated with fluid overload,
    sufficient to require treatment with diuretics, including a history of such conditions
    18. Hyponatraemia (serum sodium level <135 mmol/L) at Visit 1 (re-tested and confirmed, with
    results available within 7 days)
    19. Renal insufficiency (estimated glomerular filtration rate ≤60 mL/min)
    20. Hepatic and/or biliary diseases:
    - Child-Pugh Class A, B, or C
    - Aspartate aminotransferase and/or alanine aminotransferase levels ≥2x the upper limit of normal range
    - Total bilirubin level >1.5 mg/dL
    21. Known history of hypersensitivity to desmopressin ODT
    31. Use of any prohibited therapy listed below:
    - Current or former (within 3 months prior to screening) treatment with any other IMP
    - Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
    - Thiazide diuretics
    - V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin)
    - Loperamide
    - Botulinum toxin (cosmetic non-urological use is acceptable)
    - Valproate
    32. Subjects with a known history of type IIB or platelet-type (pseudo) von Willebrand's disease (because of the risk of platelet aggregation and thrombocytopenia).
    33. Subjects with existing medical conditions, which lead to sodium losing states such as nausea, bulimia, anorexia nervosa, chronic vomiting, diarrhoea, adrenocortical insufficiency and salt losing nephropathies.
    E.5 End points
    E.5.1Primary end point(s)
    Pearson correlation coefficient between change from baseline to Week 12 in number of nocturnal voids and the Nocturia Sleep Quality Scale (NSQS) total score
    E.5.1.1Timepoint(s) of evaluation of this end point
    please refer to section E.5.1
    E.5.2Secondary end point(s)
    - Pearson correlation coefficient between change from baseline to Weeks 1, 4 and 8 in number of nocturnal voids and the Nocturia Sleep Quality Scale (NSQS) total score
    - Pearson correlation coefficient between change from baseline to Weeks 1, 4, 8 and 12 in Patient Global Impression of Severity (PGI-S) and NSQS total score
    - Pearson correlation coefficient between PGI-I scores and change from baseline to Weeks 1, 4, 8 and 12 in NSQS total score
    - Pearson correlation coefficient between change from baseline to Weeks 1, 4, 8 and 12 in First Undisturbed Sleep Period (FUSP) and NSQS total score
    - Change from baseline in NSQS total score at Weeks 1, 4, 8 and 12 and during 12 weeks of treatment
    - Change from baseline in PGI-S scores at Weeks 1, 4, 8 and 12
    - Change from baseline in Bother as measured by the Hsu 5-point Likert Bother Scale at Weeks 1, 4, 8 and 12
    - PGI-I scores at Weeks 1, 4, 8 and 12
    - Change from baseline in number of nocturnal voids during 12 weeks of treatment
    - Change from baseline in FUSP during 12 weeks of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    please refer to section E.5.2
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    In the present trial, the association between nocturia and sleep will be investigated in adult subjects with nocturia due to Nocturnal Polyuria (NP) following treatment with desmopressin.
    In addition, sleep-related changes in metabolic biomarkers will be explored.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Czech Republic
    Hungary
    Netherlands
    United Kingdom
    United States
    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
    Trial completion is defined as when the last subject has completed the last visit in the treatment period (Visit 6).
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 138
    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 (Patients will receive local standard medical care after trial end)
    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 Decision2017-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-07-13
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