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    Summary
    EudraCT Number:2016-001638-84
    Sponsor's Protocol Code Number:16-07
    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:2016-05-17
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-001638-84
    A.3Full title of the trial
    Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study
    Thiopurines gecombineerd met een lage dosering allopurinol: een prospectieve one way cross-over studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Thiopurines with Low Dose Allopurinol: a prospective one way cross-over study
    Thiopurines gecombineerd met een lage dosering allopurinol: een prospectieve one way cross-over studie
    A.3.2Name or abbreviated title of the trial where available
    ThiLDA-study
    ThiLDA-studie
    A.4.1Sponsor's protocol code number16-07
    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 SponsorMeander Medical Center
    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 supportMeander Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMeander Medical Center
    B.5.2Functional name of contact pointSF Chavoushi
    B.5.3 Address:
    B.5.3.1Street AddressMaatweg 3
    B.5.3.2Town/ cityAmersfoort
    B.5.3.3Post code3813 TZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031612928800
    B.5.6E-mailfaraz.chavoushi@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Allopurinol Sandoz 100 mg, tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz B.V.
    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.3.8INN - Proposed INNALLOPURINOL
    D.3.9.1CAS number 315-30-0
    D.3.9.2Current sponsor codeallopurinol
    D.3.9.4EV Substance CodeSUB05338MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALLOPURINOL
    D.3.9.1CAS number 315-30-0
    D.3.9.2Current sponsor codeallopurinol
    D.3.9.4EV Substance CodeSUB05338MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Crohn's disease & Colitis Ulcerosa
    ziekte van Crohn & Colitis Ulcerosa
    E.1.1.1Medical condition in easily understood language
    inflammatory bowel diseases
    inflammatoire darmziekten, ontstoken darmziekte
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Investigating whether 50 mg allopurinol is non-inferior to 100 mg in combination with azathioprine or mercaptopurine by measuring and comparing thiopurine metabolites
    • Non-inferioriteit van 50 mg allopurinol ten opzichte van 100 mg op basis van 6-TGN en 6-MMP concentraties, te bepalen vóór en na de interventie
    E.2.2Secondary objectives of the trial
    -Comparing patient tolerability in terms of adverse events
    -comparing allopurinol concentrations
    -comparing enzyme activity for XO, TPMT and HRPT
    -comparing disease activity scores (CDAI and MAYO)
    • Aantonen van eventuele verschillen in verdraagbaarheid o.b.v. bijwerkingenprofiel voor en na de interventie
    • Bepalen en vergelijken van allopurinol spiegels voor en na de interventie
    • Het bepalen en vergelijken van de enzymactiviteit van XO, TPMT en HPRT voor en na de interventie
    • Aantonen mogelijk verschil in ziekteactiviteit o.b.v. CDAI-scores bij Crohn patiënten en Mayo scores bij Colitis Ulcerosa patiënten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Crohn's disease or Colitis Ulcerosa
    -At least one month perior usage of 100 mg allopurinol daily with azathioprine or mercaptopurine
    -at least 18 years old
    • Ziekte van Crohn of Colitis Ulcerosa
    • Ten minste één maand gebruiker van combinatie azathioprine of mercaptopurine met 100 mg allopurinol per dag
    • Leeftijd >18 jaar
    E.4Principal exclusion criteria
    -Age below 18 years old
    -Leeftijd <18 jaar
    E.5 End points
    E.5.1Primary end point(s)
    6-TGN and 6-MMP concentrations
    6-TGN en 6-MMP concentraties
    E.5.1.1Timepoint(s) of evaluation of this end point
    Right before and one month after the intervention
    Vlak vóór en één maand na de interventie
    E.5.2Secondary end point(s)
    -Frequency and incidence adverse events
    -Allopurinol concentrations
    -Enzyme activity XO, TPMT and HPRT
    -Disease activity scores (CDAI for Crohn's and Mayo for Colitis Ulcerosa)
    -Frequentie en incidentie bijwerkingen
    -Allopurinol concentraties
    -Enzymactiviteit XO, TPMT en HPRT
    -Ziekteactiviteitsscores (CDAI en Mayo bij respectievelijk Crohn's en Colitis Ulcerosa patiënten)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Right before and one month after the intervention
    Vlak vóór en één maand na de interventie
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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
    laatste bezoek laatste deelnemer
    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 months
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state22
    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
    Geen
    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 Decision2016-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
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