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    The EU Clinical Trials Register currently displays   38927   clinical trials with a EudraCT protocol, of which   6396   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2012-005808-17
    Sponsor's Protocol Code Number:HEEL-2012-04
    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:2013-03-08
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-005808-17
    A.3Full title of the trial
    The analgesic efficacy of perioperative Δ9-THC (Namisol®) in patients undergoing major abdominal surgery: 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
    Perioperative Δ9-THC for postsurgical pain
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberHEEL-2012-04
    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 Medical Centre
    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.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 pointL. Schreuder
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 9101
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post codePO Box 9101
    B.5.4Telephone number0031243610903
    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.3.9.3Other 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 2
    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 undergoing elective major abdominal surgery
    E.1.1.1Medical condition in easily understood language
    Patients undergoing elective major abdominal surgery
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10054799
    E.1.2Term Perioperative analgesia
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.2System Organ Class 100000004863
    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 perioperative Namisol® for postoperative pain in the first 5 days after abdominal surgery. Analgesic efficacy is measured as the difference in visual analog scale (VAS) area under the curve (AUC) for the first 5 postoperative days between placebo and Namisol®.
    E.2.2Secondary objectives of the trial
    To investigate the analgesic efficacy of Namisol for persistent postoperative pain after major abdominal surgery.

    To investigate the effect of Namisol on total consumption of analgesics the first 5 postoperative days.

    To investigate the effect of Namisol on total consumption of analgesics for the first 24 postoperative weeks.

    To investigate the effect of Namisol on the incidence and severity of postoperative nausea/vomiting

    To investigate the effect of Namisol on sedation level

    To investigate the effect of Namisol on central nervous system processing, and sensitization

    To evaluate the effect of Namisol on anxiety and depression, general health, pain catastrophizing, global impression of change, pain related anxiety , postoperative recovery, treatment satisfaction, and appetite

    To evaluate the effect of Namisol on safety and tolerability

    To evaluate the effect of Namisol on pharmacodynamics

    To evaluate the effects of Namisol on perioperative cytokine levels
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is between 18 and on the day the informed consent form will be signed.
    2. Patient has persistent or intermittent abdominal pain, due to underlying pathology including diverticulitis, m. Crohn, ulcerative colitis, endometriosis, or abdominal adhesions. Other pathology may be included if so judged by the investigator.
    3. Patient is undergoing elective, open abdominal surgery with planned use of an epidural catheter the surgical procedure has an estimated duration of at least two hours, not including the time to induce anesthesia.
    4. Patient scores I to III in the American Society of Anesthesiologists physical status classification system (ASA I-III).
    5. Patient has a stable medication regimen of analgesics for at least 2 weeks prior to study entry.
    6. Patient is willing and able to comply with the lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other trial procedures.
    7. 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 is diagnosed with chronic pancreatitis, ACNES, abdominal hernia, inguinal hernia, abdominal wall pathology or intestinal fistula.
    2. Patient suffers from persistent or intermittent abdominal pain (on a daily basis in at least 3 months) with average NRS ≥ 3, based or probably based on past abdominal surgery or other causes for the pain, for example, continuing malignancy, chronic infection or from diabetes mellitus.
    3. Patient has an unstable regimen of analgesics or a regimen of analgesics which includes tricyclic antidepressants or 2--binding Ca++ channel blockers such as gabapentin.
    4. Patient is ineligible for the anesthesia protocol, as judged by the investigator.
    5. Patient is admitted to the hospital on the day of surgery itself
    6. Patient used any cannabinoids (by smoking cannabis or oral intake) for at least one month on the day of screening.
    7. Patient has a (history of) a malignant or other significant medical disorder that, in the opinion of the investigator, may interfere with the study or may pose a risk for the patient, including terminal illness.
    8. Patient uses 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).
    9. Patient does not tolerate oral intake of food/liquids or is refrained from oral intake because of medical reasons.
    10. Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG) parameters at screening.
    11. Patient is at the moment of screening diagnosed with moderate to severe renal impairment as judged by the investigator.
    12. Patient is at the moment of screening diagnosed with moderate to severe hepatic failure as judged by the investigator.
    13. Patient has a presence or history of major psychiatric illness as judged by the 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 known history of alcohol or substance abuse.
    16. 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.
    17. Patient demonstrates a positive urine drug screen at screening visit for THC, cocaine, MDMA, and amphetamines.
    18. Female patient is pregnant (childbearing potential must have a negative pregnancy test prior to each study day) or breastfeeding during the course of the study.
    19. Female childbearing potential has to use acceptable birth control measures including oral contraceptives, intrauterine devices or mechanical methods.
    20. Patient intends to conceive 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)
    o Short-term postoperative pain intensity
     Daily VAS average pain
    E.5.1.1Timepoint(s) of evaluation of this end point
    Repeatedly, from five days before surgery (-5, baseline) up to +6 postoperative months
    E.5.2Secondary end point(s)
    o Long-term postoperative pain intensity
     Weekly pain diary
    o Short-term postoperative consumption of analgesics
     Number of PCA requests and deliveries
     Total dose of escape medication
    o Long-term postoperative consumption of analgesics
     Post-discharge use of analgesics
    o Central nerve system processing and sensitization
     QST (focal and peripheral)
    • Pressure pain thresholds
    • Electric pain thresholds
    • Electric wind-up response
     Conditioned Pain Modulation (CPM)
     Sensitization
    • Peri-incisional Von Frey filament testing
    • Peri-incisional brush stroke testing
    o Questionnaires
     VAS Bond & Lader
     VAS Bowdle
     HADS
     SF-36
     PCS
     PGIC
     PASS
     QoR-40
     AppLe
     TSQM v. II
    o Postoperative sedation level
     Ramsay sedation score
    o Postoperative nausea and vomiting (PONV)
     Incidence of nausea and vomiting
     Rescue medication
    o Immune system response
     TNF-
     Interleukins IL-1, IL-6 and IL-10
     Matrix metalloproteases MMP-2 and MMP-9
    o Pharmacogenetics
    o Safety
     Laboratory
     ECG
     HF and BP
     Adverse events, including postoperative nausea/vomiting
    E.5.2.1Timepoint(s) of evaluation of this end point
    Repeatedly, from twenty days before surgery (-20, baseline) up to +6 postoperative months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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. 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
    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: 40
    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 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 state40
    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 treatment will not interfere with or have any consequences for the initial treatment plan. Subjects will receive extended treatment 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 Decision2013-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-11-17
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