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    The EU Clinical Trials Register currently displays   43234   clinical trials with a EudraCT protocol, of which   7153   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:2012-000730-19
    Sponsor's Protocol Code Number:HEEL-2011-02
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-12
    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 number2012-000730-19
    A.3Full title of the trial
    The analgesic efficacy of Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Δ9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain
    A.3.2Name or abbreviated title of the trial where available
    Delta-Pain II
    A.4.1Sponsor's protocol code numberHEEL-2011-02
    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.4.1Name of organisation providing supportEFRO
    B.4.2CountryEuropean Union
    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 pointM. de Vries
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 9101
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003124 3610903
    B.5.5Fax number0031243540501
    B.5.6E-mailm.devries@chir.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 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 nameNamisol
    D.3.2Product code A04AD10
    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 INNDRONABINOL
    D.3.9.1CAS number 03/08/1972
    D.3.9.3Other descriptive nameTetrahydro-6,6,9-tri methyl-3-penthyl-6 H-dibenzo[ b,d ]pyran-1-ol
    D.3.9.4EV Substance CodeSUB06407MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.75 to 5.0
    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 Yes
    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 placeboTablet
    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
    Chronic pancreatitis with persistant abdominal pain
    E.1.1.1Medical condition in easily understood language
    Chronic inflammation of the pancreas
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033649
    E.1.2Term Pancreatitis chronic
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To investigate the analgesic efficacy of Namisol® after a stable dose, including step-up, treatment of Δ9-THC on the experienced pain intensity in chronic pancreatitis patients suffering from persistent abdominal pain.
    E.2.2Secondary objectives of the trial
    - To investigate the efficacy of Namisol® after a stable dose, including step-up, treatment of Δ9-THC on experimental pain mechanisms (measured by EEG, QST, and DNIC) in chronic pancreatitis patients suffering from persistent abdominal pain.
    - To investigate the efficacy of Namisol® after a stable dose, including step-up, treatment of Δ9-THC on quality of life, depression, anxiety and catastrophizing in chronic pancreatitis patients suffering from persistent abdominal pain.
    - To evaluate the safety and tolerability (adverse events) of Namisol® after a stable dose, including step-up, treatment of Δ9-THC in chronic pancreatitis patients suffering from persistent abdominal pain.
    - To evaluate the pharmacokinetics (PK) and pharmacodynamic (PD) effects (body sway, HF, feeling high) of Namisol® after a stable dose, including step-up, treatment of Δ9-THC in chronic pancreatitis patients suffering from persistent abdominal pain.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Aged 18 years or older
    •Confirmed chronic pancreatitis
    •Pain duration exceeding 3 months, and average NRS≥3
    •Stable doses intake of analgesics for the past 2 months
    •The patient has been informed about the study, understood the information and signed the informed consent form
    E.4Principal exclusion criteria
    •Patient took cannabinoids on a regular basis for at least one year
    •Patient does not feel a pinprick test in the lower extremities
    •Patient has a body mass index (BMI) above 32,0 kg/m2
    •Patient suffers from serious painful conditions other than chronic pancreatitis
    •Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
    •Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
    •Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
    •Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
    •Patient has an actual moderate to severe renal impairment
    •Patient has an actual moderate to severe hepatic impairment
    •Patient has a presence or history of major psychiatric illness
    •Patient has experienced an epileptic seizure in the past
    •Patient demonstrates clinically significant laboratory abnormalities
    •Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines
    •Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test
    •Patient has a history of sensitivity / idiosyncrasy to THC
    •Patient has a known or suspected lactose intolerance
    •Female patient is pregnant or breastfeeding
    •Patient intends to conceive a child during the course of the study
    •Patient participates in another investigational drug study
    •Patient has a clinical significant exacerbation in illness
    •Patient is unwilling or unable to comply with the lifestyle guidelines
    E.5 End points
    E.5.1Primary end point(s)
    • Pain intensity (diary)
    o VAS average pain
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 (baseline) versus day 52
    E.5.2Secondary end point(s)
    • Pain intensity (diary)
    o VAS minimal pain
    o VAS maximal pain
    • EEG
    o ERPs to noxious electrical stimuli
    o ERPs to auditory stimuli (oddball)
    o FFT spontaneous EEG
    • QST (visceral screenings protocol)
    o Pressure pain thresholds
    o Electric pain thresholds
    o Electric wind-up response
    o DNIC
    • Questionnaires
    o Izbicki
    o PGIC
    o PCS
    o VASBond & Lader
    o VASBowdle
    o SF-36
    o HADS
    • Pharmacodynamics
    o Body Sway
    • Functional
    o Body weight
    o Supplementary feeding
    • Safety
    o Laboratory
    o ECG
    o HF / BP
    o Adverse events
    • Pharmacokinetics
    o THC, 11-OH-THC and THC-COOH concentrations
    E.5.2.1Timepoint(s) of evaluation of this end point
    Repeatedly, from day 0 (baseline) versus day 52
    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 Yes
    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 trial2
    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
    last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months10
    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: 68
    F.1.3Elderly (>=65 years) No
    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 state68
    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)
    The IMP teratment will not interfeer or have any consequences with the initial treatment plan. Subjects will not be prolonged treated with the IMP after participation.
    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 Decision2012-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-09-03
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