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    Summary
    EudraCT Number:2011-005970-41
    Sponsor's Protocol Code Number:SDW-001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-08
    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 number2011-005970-41
    A.3Full title of the trial
    The effect of acetazolamide on lithium-induced nephrogenic diabetes insipidus in patients with an affective disorder: a pilot study
    Het effect van acetazolamide op lithium-geïnduceerde nefrogene diabetes insipidus bij patiënten met een affectieve stoornis: een pilot onderzoek
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of the drug acetazolamide on excessive urine production due to a diminished concentrating ability of the kidney as a result of the use of lithium in patients with an affective disorder: a pilot study
    Het effect van het geneesmiddel acetazolamide op overmatige urineproductie door een verminderd concentrerend vermogen van de niet als gevolg van lithiumgebruik door patienten met een affectieve stoornise: een pilot study
    A.4.1Sponsor's protocol code numberSDW-001
    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 SponsorRadboud University Nijmegen Medical Centre
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRadboud University Nijmegen Medical Centre
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Nijmegen Medical Centre
    B.5.2Functional name of contact pointAcetazolamide - pilot study
    B.5.3 Address:
    B.5.3.1Street AddressPostbus 9101
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00312436114761
    B.5.5Fax number0031243540022
    B.5.6E-mailj.doornebal@aig.umcn.nl
    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 Acetazolamide Sandoz 250
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 59-66-5
    D.3.9.3Other descriptive nameACETAZOLAMIDE
    D.3.9.4EV Substance CodeSUB05219MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    lithium-induced nephrogenic diabetes insipidus
    lithium-geïnduceerde nefrogene diabetes insipidus
    E.1.1.1Medical condition in easily understood language
    excessive urine production due to a diminished concentrating ability of the kidney
    overmatige urineproductie door een verminderd concentrerend vermogen van de nier
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012600
    E.1.2Term Diabetes insipidus nephrogenic
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10050501
    E.1.2Term Lithium toxicity
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the effect of acetazolamide on lithium-induced nephrogenic diabetes insipidus measured as urine volume and maximal urinary osmolality.
    Bestuderen van het effect van acetazolamide op lithium-geïnduceerde nefrogene diabetes insipidus m.b.t. de urineproductie en maximale urine osmolaliteit.
    E.2.2Secondary objectives of the trial
    To explore the possible changes in subjective symptoms (frequency of micturition); vital signs (body weight and blood pressure); blood levels of sodium, potassium, chloride, bicarbonate, lithium, creatinine, haemoglobin and osmolality; urine levels of sodium, potassium, osmolality, urea and creatinine in morning spot urine samples; side effects of acetazolamide treatment; and psychiatric outcome.
    Bestuderen van de eventuele verandering in subjectieve symptomen (mictie frequentie); vitale parameters (lichaamsgewicht en bloeddruk); serum concentraties van natrium, kalium, chloor, bicarbonaat, lithium, kreatinine, hemoglobine en osmolaliteit; urine concentraties van natrium, kalium, osmolaliteit, ureum en kreatinine in een portie ochtendurine; bijwerkingen van acetazolamide; en de psychiatrische uitkomst.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    men and women
    age > 18 years
    stable patients treated with lithium for an affective disorder
    moderate to severe lithium-induced nephrogenic diabetes insipidus (max. urinary concentration >150 and <600 mOsm)
    mannen en vrouwen
    leeftijd >18 jaar
    stabiele patiënten behandeld met lithium voor een affectieve stoornis
    matig tot ernstige lithium-geïnduceerde nefrogene diabetes insipidus (max. urine concentratie >150 en <600 mOsm)
    E.4Principal exclusion criteria
    pregnancy
    diabetes mellitus
    underlying renal disorders
    significant cardiac/pulmonary comorbidity
    heart rhythm disorders
    pre-existent side effects of lithium treatment
    treatment with hydrochlorothiazide or amiloride in the preceding 2 weeks
    concomittant treatment with other diuretics
    hypotension (systolic blood pressure < 100 mm Hg)
    renal insufficiency
    hypo/hyperkalemia
    hypercalcaemia
    hypo/hyperthyroidism
    zwangerschap
    diabetes mellitus
    onderliggende nieraandoening
    significante cardiale/pulmonale comorbiditeit
    hartritmestoornissen
    pre-existente bijwerkingen van de behandeling van lithium
    behandeling met hydrochloorthiazide of amiloride in de voorafgaande 2 weken
    gelijktijdige behandeling met overige diuretica
    hypotensie (systolische bloeddruk < 100 mm Hg)
    nierinsufficiëntie
    hypo/hyperkaliëmie
    hypercalciëmie
    hypo/hyperthyreoïdie
    E.5 End points
    E.5.1Primary end point(s)
    urine volume and maximal urinary osmolality after dDAVP administration
    urine volume en maximale urine osmolaliteit na toediening van dDAVP
    E.5.1.1Timepoint(s) of evaluation of this end point
    urine volume:
    - daily (questionnaire)
    - day -7, 0, 7, 14, 21, 28 and 42 (24 h urine collection)

    maximal urinary osmolality after dDAVP administration:
    - day -7 and 28 (before and during treatment with acetazolamide)
    urine volume:
    - dagelijks (vragenlijst)
    - dag -7, 0, 7, 14, 21, 28 en 42 (24 uurs urine verzameling)

    maximale urine osmolaliteit na toediening van dDAVP:
    - dag - 7 en 28 (voor en tijdens behandeling met acetazolamide)
    E.5.2Secondary end point(s)
    changes in subjective symptoms (frequency of micturition); vital signs (body weight and blood pressure); blood levels of sodium, potassium, chloride, bicarbonate, lithium, creatinine, haemoglobin and osmolality; urine levels of sodium, potassium, osmolality, urea and creatinine in morning spot urine samples; side effects of acetazolamide treatment; and psychiatric outcome.
    veranderingen in subjectieve symptomen (mictie frequentie); vitale parameters (lichaamsgewicht en bloeddruk); serum concentraties van natrium, kalium, chloor, bicarbonaat, lithium, kreatinine, hemoglobine en osmolaliteit; urine concentraties van natrium, kalium, osmolaliteit, ureum en kreatinine in een portie ochtendurine; bijwerkingen van de behandeling met acetazolamide; en pyschiatrische uitkomst.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All above mentioned items:
    - day -7, 0, 7, 14, 21, 28 and 42
    Alle bovengenoemde items:
    - dag -7, 0, 7, 14, 21, 28 en 42
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned 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
    In this pilot study only 6 patients will be included. After 3 patients are included, an interim analysis of the effect of acetazolamide on urine osmolality will be performed. The study will end if:
    a. none of the first 3 patients show an increase in urine osmolality (>50 mOsm/kg), or
    b. 6 patients are included.
    In dit pilot onderzoek wordt gestreefd naar een inclusie van 6 patiënten. Na inclusie van de eerste 3 patiënten zal een interim analyse worden verricht m.b.t. het effect van acetazolamide op de urine osmolaliteit. De studie zal worden beëindigd indien:
    a. geen van de eerste drie patiënten een toename laat zien van de urine osmolaliteit >50 mOsm/kg, of
    b. 6 patiënten zijn geïncludeerd.
    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 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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state6
    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)
    If patients respond to the treatment with acetazolamide, this drug can be prescribed 'off-label' after the patient has ended the participation in the trial
    Als de patiënt respondeert op de behandeling met acetazolamide kan dit geneesmiddel 'off-label' worden voorgeschreven na beëindiging van deelname aan dit onderzoek
    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 Decision2012-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-27
    P. End of Trial
    P.End of Trial StatusOngoing
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