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    Summary
    EudraCT Number:2011-003208-19
    Sponsor's Protocol Code Number:GWID10160
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-28
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-003208-19
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    GWP42003 symptomatic treatment of ulcerative colitis.
    A.4.1Sponsor's protocol code numberGWID10160
    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 SponsorGW Pharma Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGW Pharma Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGW Pharma Ltd.
    B.5.2Functional name of contact pointGW Pharma Ltd. Switchboard
    B.5.3 Address:
    B.5.3.1Street AddressPorton Down Science Park
    B.5.3.2Town/ citySalisbury
    B.5.3.3Post codeSP4 0JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441980557000
    B.5.5Fax number+441980557111
    B.5.6E-mailinfo@gwpharm.com
    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.3.2Product code GWP42003
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot applicable
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor codeGWP42003
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeActive ingredient extracted from Cannabis Sativa L.
    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
    Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
    E.1.1.1Medical condition in easily understood language
    Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of GWP42003 compared with placebo by the percentage of participants achieving remission quantified as a MAYO score of 2 or less (with no subscore>1) after 10 weeks treatment.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of GWP42003 compared with placebo on:
    • C-reactive protein (CRP)
    • Plasma levels of inflammatory cytokines
    • Faecal inflammatory markers
    • Inflammatory Bowel Disease Questionnaire (IBDQ)
    • Subject’s global impression of change (SGIC)
    • Physician’s global assessment of illness severity (PGAS)
    • Stool frequency (NRS scale)
    • Rectal bleeding (NRS scale)
    • Pain Score (NRS scale)
    • Endocannabinoid plasma levels as an exploratory endpoint (where required storage
    facilities allow)
    • MAYO score
    • Responder analysis defined as participants at the end of treatment
    with a decrease in their MAYO score of ≥3 compared to
    baseline (with a reduction of at least 1 in endoscopic subscore).
    • Body weight
    To assess the safety and tolerability of GWP42003 compared with
    placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female participants aged 18 years or above;
    • Participant diagnosed with mild to moderate ulcerative colitis and on a fixed dose of 5-ASA treatment and have been on a stable dose for at least 2 weeks prior to screening;
    • Participants at screening (Visit 1) and baseline (Visit 2) with a MAYO assessment score of greater than or equal to 4 (≥4) but less than or equal to 10 (≤10) and with an endoscopy score of at least 1 (≥1) following an adequate exposure to oral and/or topical 5-ASA in the opinion of the investigator;
    • In the opinion of the investigator, capable of complying with the study requirements and completing the study;
    • Willing and able to give informed consent;
    • Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable;
    • Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study
    E.4Principal exclusion criteria
    • Severe ulcerative colitis (MAYO score of greater than 10 (>10)).
    • Ulcerative colitis only affecting the rectum i.e. Proctitis
    • Infection evident from stool culture and testing for clostridium difficile toxin (in the opinion of the investigator);
    • Currently using or has used recreational cannabis, medicinal cannabis, cannabinoid medications (including Sativex®), or synthetic cannabinoid based medications within one month prior to study entry and unwilling to abstain for the duration of the study;
    • Any known or suspected history of:
    - alcohol or substance abuse
    - epilepsy or recurrent seizures
    - hypersensitivity to cannabinoids
    • Receiving a prohibited medication according to the protocol prior to screening and for the duration of the study;
    • Previous non-responders to mono or polyclonal anti-Tumour Necrosis Factor antibodies;
    • Personal or first degree relative, with history of schizophrenia, other psychotic illness, severe personality disorder, or other significant psychiatric disorder;
    • Any known or suspected history of depression sufficient to require treatment with antidepressants or disrupt ordinary life (excluding episodes of reactive depression at the discretion of the investigator);
    • Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator;
    • Female participant who is pregnant, lactating or planning pregnancy during the course of the study and for 3 months from the date of last dose;
    • Female participant of child bearing potential, unless willing to use two forms of contraception, one of which must be a barrier contraception (e.g. female condom or occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months from the date of last dose (however a male condom should not be used in conjunction with the female condom);
    • Male participants whose partner is of child bearing potential, unless willing to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (e.g. occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months from date of last dose (however a male condom should not be used in conjunction with a female condom);
    • Travel outside the country of residence planned during the treatment phase of the study;
    • Received an Investigational Medicinal Product (IMP) within 30 days prior to the screening visit;
    • In the opinion of the investigator, is not considered to be suitable for the study;
    • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, may influence the result of the study, or the participant’s ability to participate in the study;
    • Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator would prevent the participant from safe participation in the study;
    • Unwilling to abstain from donation of blood during the study;
    • Previously randomised into this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the percentage of subjects at the end of treatment achieving remission quantified as a MAYO score of 2 or less (with no subscore>1) after 10 weeks treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 weeks post treatment (with potential added time to allow for visit windows)
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • CRP
    • Plasma Il-2, Il-6, TNFα
    • Faecal calprotectin
    • IBDQ
    • SGIC
    • PGAS
    • Stool frequency (NRS scale)
    • Rectal bleeding (NRS scale)
    • Pain Score (NRS scale)
    • Endocannabinoid plasma levels as an exploratory endpoint (where required storage
    facilities allow)
    • MAYO score
    • Number of subjects at the end of treatment with a decrease in
    their MAYO score of 3 or more compared to baseline (with a
    reduction of at least 1 in endoscopic subscore)
    • Body Weight
    Secondary Safety Endpoints:
    • To assess the safety and tolerability of GWP42003 compared with placebo in terms of the incidence, type and severity of AEs, and changes in vital signs, ECG, laboratory and physical examination parameters.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 weeks post treatment (with potential added time to allow for visit windows)
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    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) 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 62
    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)
    Normal standard of care will resume as clinical evidence of the efficacy of these medicines in this population of participants has yet to be determined.
    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 Decision2011-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-08-04
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