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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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:2011-000647-24
    Sponsor's Protocol Code Number:HEEL-2011-01
    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:2011-05-12
    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 number2011-000647-24
    A.3Full title of the trial
    The safety, tolerability, and analgesic efficacy of Δ9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy study of Δ9-THC to treat persistent abdominal pain as a result of chronic pancreas inflammation
    A.3.2Name or abbreviated title of the trial where available
    Δ9-THC in chronic pain
    A.4.1Sponsor's protocol code numberHEEL-2011-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01318369
    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 supportGO EFRO
    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 Addresshuispost 690; PObox 9101
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031 243610903
    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 1972-08-3
    D.3.9.4EV Substance CodeSUB06407MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number5
    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
    patients with abdominal pain as a result of chronic pancreatitis
    E.1.1.1Medical condition in easily understood language
    Chronic inflammation of the pancreas
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10033649
    E.1.2Term Pancreatitis chronic
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10009093
    E.1.2Term Chronic pancreatitis
    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 efficacy of Namisol® after a single dose of THC on the experienced pain intensity (measured by the VASpain) in patients with chronic pancreatitis.
    E.2.2Secondary objectives of the trial
    - To investigate the efficacy of Namisol® after a single dose of THC on experimental pain mechanisms (measured by EEG, QST, and DNIC) in patients with chronic pancreatitis.
    - To evaluate the safety and tolerability of Namisol® after a single dose of THC in patients with chronic pancreatitis.
    - To evaluate the pharmacokinetics (PK) of Namisol® after a single dose of THC in patients with chronic pancreatitis.
    - To evaluate (undesirable) pharmacodynamic (PD) effects of Namisol® after a single dose of THC in patients with chronic pancreatitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is 18 years or older on the day the informed consent form will be signed.
    2. Patient is male.
    3. Patient has chronic pancreatitis, diagnosed using the Marseille and Cambridge Classification System (addendum II).37
    4. Patient suffers from chronic abdominal pain typical for pancreatitis, meet the criteria for chronic pain (intermittent or persistent pain on a daily basis in at least 3 months), and must consider their pain as severe enough for medical treatment (average NRS ≥ 3).
    5. Patient in de opioid subgroup takes stable doses of opioids, e.g. morphine or tramadol, for the past 2 months on the day of screening. Stable dose intake is defined as a daily equivalent sum of opioid intake according medical prescription within a small deviation range as judged by the investigator.
    6. Patient in the non-opioid group does not take any opioids for the past 2 months on the day of screening.
    7. Patient is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
    8. Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
    E.4Principal exclusion criteria
    1. Patient did not took any cannabinoid (by smoking cannabis or oral intake) for at least one year on the day of screening.
    2. Patient is insulin depended for more than 5 years on the day of screening.
    3. Patient does not feel a pinprick test in the lower extremities, due to affected sensory input (e.g. neuropathy as a result of diabetes mellitus).
    4. Patient has a body mass index (BMI) below 18 or above 31.2 kg/m2.
    BMI (kg/m²) = weight (kg) / (height * height) (m2)
    5. Patient suffers from serious painful conditions other than chronic pancreatitis or had any major pre-existing chronic pain syndrome.
    6. Patient has a (history of) a significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient.
    7. Patient uses any kind of concomitant medication that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient (e.g. HIV antivirals or proton-pump inhibitors).
    8. Patient takes drip-feed.
    9. Patient takes amitriptyline on a daily base and is unable/unwilling to refrain from amitriptyline from 24 hours before each study day.
    10. Patient demonstrates deviating ECG parameters at screening, e.g. heart rate >100 bpm, QRS duration >120 msec, QTc interval >450 msec, PR interval >210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
    11. Patient is previously diagnosed with moderate to severe renal impairment, e.g. creatinine values > 2x ULN and/or a significant change of their normal values.
    12. Patient is previously diagnosed with moderate to severe hepatic failure or show significant clinical abnormalities in biochemistry blood sample.
    13. Patient has a presence or history of major psychiatric illness as judged by investigator, e.g. major depression, schizophrenia.
    14. Patient demonstrates clinically significant laboratory abnormalities that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
    15. Patient has a history of sensitivity / idiosyncrasy to THC, compounds chemically related to these compounds, or to any other related drug used in the past.
    16. Patient shows a positive alcohol breath test at screening or admission and/or is unable/unwilling to refrain from alcohol use from 48 hours before each study day until the last blood sample has been drawn.
    17. Patient demonstrates a positive urine screen at screening visit for THC, cocaine, MDMA, and amphetamines.
    18. Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test.
    19. Patient is unwilling or unable to comply with the lifestyle guidelines.
    20. Patients intends to father a child during the course of the study.
    21. Patient participates in another investigational drug study within 90 days prior to the first dose and/or participates in more than 2 clinical trials in the last year.
    22. Patient has a clinical significant exacerbation in illness within two weeks of participating in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Pain intensity:
    - VAS pain rest
    - VAS pain movement

    E.5.1.1Timepoint(s) of evaluation of this end point
    Repeatedly; baseline until 6 hours after single dose administration
    E.5.2Secondary end point(s)
    EEG; ERPs to noxious stimuli and spontaneous EEG
    QST; mechanical and electrical pain thresholds
    Body Sway; static 2 dimensional body sway
    E.5.2.1Timepoint(s) of evaluation of this end point
    Repeatedly; baseline until 6 hours after administration
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    active placebo: diazepam
    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 Information not present in EudraCT
    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
    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 years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    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.1.1Number of subjects for this age range: 24
    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: 24
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state24
    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)
    Subjects will receive a single dose of IMP, which 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 Decision2011-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-26
    P. End of Trial
    P.End of Trial StatusCompleted
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