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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-010266-28
    Sponsor's Protocol Code Number:7UMCNHE7368463
    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:2009-01-29
    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 number2009-010266-28
    A.3Full title of the trial
    Een gerandomiseerde dubbelblinde, placebogecontroleerde, klinische parallelle groep studie van pregabaline in patiënten met chronische pancreatitis
    A.3.2Name or abbreviated title of the trial where available
    Effect van pregabaline therapie bij patiënten met chronische pancreatitis
    A.4.1Sponsor's protocol code number7UMCNHE7368463
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAfdeling heelkunde, Universitair Medisch Centrum Sint Radboud
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Lyrica®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronische pancreatitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009093
    E.1.2Term Chronic pancreatitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    pijnverlichting
    E.2.2Secondary objectives of the trial
    verandering in kwaliteit van leven
    verdragen van medicament vs placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Mannen of vrouwen in de leeftijd van 18 tot 70 jaar met de diagnose chronische pancreatitis, gediagnosticeerd volgens de Marseille-Rome/Cambridge diagnostische criteria. Diabetische en niet-diabetische patiënten worden beide toegelaten tot de studie.
    2. Patiënten met chronische abdominale pijn, typerend voor pancreatitis, die voldoen aan de criteria voor chronische pijn (beschreven als pijn >/= 3 dagen per week in op zijn minst 3 maanden) en deze pijn beschouwen als ernstig genoeg voor medische behandeling.
    3. Persoonlijke ondertekend en gedateerd informed consent document, wat aangeeft dat de patiënt is geïnformeerd over alle aspecten van de trial.
    4. Patiënten die bereidt zijn om zich te houden aan de geplande bezoeken, het behandelingsplan, laboratoriumonderzoeken en andere trial procedures.
    E.4Principal exclusion criteria
    1. Patiënten met een historie of aanwezigheid van een aandoening, die naar inzicht van de onderzoeker, van belang is voor de studie.
    2. De aanwezigheid of historie van een ernstige depressie.
    3. Patiënten met een gediagnosticeerd matige tot ernstige nierfunctiestoornis. Patiënten met een kreatinine waarde groter dan 2x de normaal waarde en/of een significante verandering van hun normaalwaarde.
    4. Patiënten met een 12-lead ECG en volgende bevindingen: hartfrequentie >100 bpm, QRS interval > 120msec, QTc interval >450 msec, PR interval >210 msec, elke klinisch significante ritme afwijking, myocard ischemie of letsel.
    5. Patiënten met klinisch significante laboratorium afwijkingen, die naar de mening van de onderzoeker het risico verhogen geassocieerd met participatie in de trial of interfereert met de interpretatie van de studieresultaten.
    6. Patiënten behandeld met pregabaline (Lyrica®) gedurende de voorgaande 4 maanden.
    7. Behandeling met een experimenteel medicament gedurende de voorgaande 4 maanden voor de 1e gift van pregabaline, geschat naar waarde door de onderzoeker.
    8. Vrouwelijke patiënten die borstvoeding geven, zwanger zijn of de wil hebben om zwanger te worden. Mannen die de intentie hebben om een kind op te voeden gedurende het verloop van de studie. Een zwangerschapstest zal worden uitgevoerd om uit te sluiten dat vrouwen zwanger zijn tijdens het 1e en 3e bezoek.
    9. Patiënten die niet bereidt zijn zich te houden aan de levensstijl richtlijnen.
    10. Patiënten mogen geen andere pijnlijke aandoening hebben naast chronische pancreatitis.
    11. Klinisch significante ziekte binnen twee weken voor aanvang van de studie.
    12. Participatie in het plannen of uitvoeren van deze studie.
    13. Overgevoeligheid voor pregabaline of bestanddelen van het medicament.
    E.5 End points
    E.5.1Primary end point(s)
    De primaire uitkomstmaat die geëvalueerd zal worden is pijnverlichting. In het klinische gedeelte zal de verandering in de dagelijkse pijnbeleving worden beoordeeld aan de hand van vragenlijsten.
    In het experimentele gedeelte zal het analgesie effect worden beoordeeld aan de hand van experimentele eindpunten( zoals QST parameters). Alle veranderingen zullen worden vergeleken met standaard meetpunten.
    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) 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    F.3.3.3 toxiciteit is aangetoond in diermodellen
    F.3.3.4 werkzame substantie is aangetoond in moedermeld in diermodellen
    F.3.3.6 informed consent is nodig voor inclusie
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    ernstige depressie, nierfalen en hartstoornissen
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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 Decision2009-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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