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    Clinical Trial Results:
    A randomised, double blind, placebo controlled, parallel group, dose ranging study of GWP42004 as add on to metformin in the treatment of participants with Type 2 diabetes.

    Summary
    EudraCT number
    2013-001140-61
    Trial protocol
    GB  
    Global end of trial date
    29 Dec 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Sep 2018
    First version publication date
    23 Sep 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GWDM1302
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02053272
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GW Research Ltd
    Sponsor organisation address
    Sovereign House, Vision Park, Chivers Way, Histon, Cambridge, United Kingdom, CB24 9BZ
    Public contact
    Alternate contact: medinfo@greenwichbiosciences.com, GW Research Ltd, medinfo@gwpharm.com
    Scientific contact
    Alternate contact: medinfo@greenwichbiosciences.com, GW Research Ltd, medinfo@gwpharm.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of 2, 5 and 15 milligrams (mg) twice daily of GWP42004 compared with placebo by assessing the impact of treatment on glycaemic control in the treatment of participants with Type 2 diabetes.
    Protection of trial subjects
    This trial was conducted in compliance with International Conference on Harmonisation Good Clinical Practice guidelines for conducting, recording, and reporting trials, as well as for archiving essential documents. Consistent with ethical principles for the protection of human research participants, no study procedures were performed on study participants until written consent had been obtained from them. The informed consent form, protocol, and amendments for this trial were submitted to and approved by the Institutional Review Board or Ethics Committee at each participating trial site.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Mar 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 166
    Country: Number of subjects enrolled
    United Kingdom: 41
    Worldwide total number of subjects
    207
    EEA total number of subjects
    207
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    139
    From 65 to 84 years
    68
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Adult participants had been diagnosed with type 2 diabetes, received oral metformin (≥1000 mg/day) for ≥3 months prior to screening, maintained stable metformin dose for trial duration, had not taken insulin in the last year, had glycosylated haemoglobin A1c (HbA1c) levels >7% - ≤9%, and body mass index (BMI) >23 - <40 kilograms (kg)/metre (m)^2.

    Period 1
    Period 1 title
    Baseline, Treatment, Follow-up (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GWP42004, 2 mg twice daily
    Arm description
    Participants self-administered oral, active investigational medicinal product (IMP) GWP42004, 2 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.
    Arm type
    Experimental

    Investigational medicinal product name
    GWP42004
    Investigational medicinal product code
    Other name
    Δ9-tetrahydrocannabivarin
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42004 was presented as a hard gelatin capsule containing 2 mg GWP42004 (Δ9-tetrahydrocannabivarin) and excipients macrogolglycerol ricinoleate and oleoyl macrogol-6-glycerides. The capsule shells contained indigo carmine - Federal Food, Drug, and Cosmetic (FD&C) blue number 2, titanium dioxide (E171), and yellow iron oxide colourings.

    Arm title
    GWP42004, 5 mg twice daily
    Arm description
    Participants self-administered oral, active IMP GWP42004, 5 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.
    Arm type
    Experimental

    Investigational medicinal product name
    GWP42004
    Investigational medicinal product code
    Other name
    Δ9-tetrahydrocannabivarin
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42004 was presented as a hard gelatin capsule containing 5 mg GWP42004 (Δ9-tetrahydrocannabivarin) and excipients macrogolglycerol ricinoleate and oleoyl macrogol-6-glycerides. The capsule shells contained indigo carmine - FD&C blue number 2, titanium dioxide (E171), and yellow iron oxide colourings.

    Arm title
    GWP42004, 15 mg twice daily
    Arm description
    Participants self-administered oral, active IMP GWP42004, 15 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.
    Arm type
    Experimental

    Investigational medicinal product name
    GWP42004
    Investigational medicinal product code
    Other name
    Δ9-tetrahydrocannabivarin
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    GWP42004 was presented as a hard gelatin capsule containing 15 mg GWP42004 (Δ9-tetrahydrocannabivarin) and excipients macrogolglycerol ricinoleate and oleoyl macrogol-6-glycerides. The capsule shells contained indigo carmine - FD&C blue number 2, titanium dioxide (E171), and yellow iron oxide colourings.

    Arm title
    Placebo, twice daily
    Arm description
    Participants self-administered oral placebo in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical to GWP42004 treatment arms.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was presented as a hard gelatin capsule containing excipients macrogolglycerol ricinoleate and oleoyl macrogol-6-glycerides. The capsule shells contained indigo carmine - FD&C blue number 2, titanium dioxide (E171), and yellow iron oxide colourings.

    Number of subjects in period 1
    GWP42004, 2 mg twice daily GWP42004, 5 mg twice daily GWP42004, 15 mg twice daily Placebo, twice daily
    Started
    54
    53
    52
    48
    Received at Least 1 Dose of Study Drug
    54
    53
    52
    48
    Safety Population
    54
    53
    52
    48
    Intent to Treat (ITT) Population
    52
    53
    52
    48
    Completed
    48
    50
    48
    47
    Not completed
    6
    3
    4
    1
         Met protocol specified withdrawal criteria
    1
    1
    -
    -
         Withdrawn by investigator
    1
    -
    1
    -
         Adverse event, non-fatal
    2
    -
    3
    -
         Consent withdrawn by subject
    1
    2
    -
    1
         Lost to follow-up
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GWP42004, 2 mg twice daily
    Reporting group description
    Participants self-administered oral, active investigational medicinal product (IMP) GWP42004, 2 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    GWP42004, 5 mg twice daily
    Reporting group description
    Participants self-administered oral, active IMP GWP42004, 5 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    GWP42004, 15 mg twice daily
    Reporting group description
    Participants self-administered oral, active IMP GWP42004, 15 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    Placebo, twice daily
    Reporting group description
    Participants self-administered oral placebo in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical to GWP42004 treatment arms.

    Reporting group values
    GWP42004, 2 mg twice daily GWP42004, 5 mg twice daily GWP42004, 15 mg twice daily Placebo, twice daily Total
    Number of subjects
    54 53 52 48 207
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    36 31 39 33 139
        From 65-84 years
    18 22 13 15 68
        85 years and over
    0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60.4 ± 8.83 61.4 ± 8.96 59.2 ± 9.59 59.5 ± 8.81 -
    Gender categorical
    Units: Subjects
        Female
    25 23 24 25 97
        Male
    29 30 28 23 110

    End points

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    End points reporting groups
    Reporting group title
    GWP42004, 2 mg twice daily
    Reporting group description
    Participants self-administered oral, active investigational medicinal product (IMP) GWP42004, 2 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    GWP42004, 5 mg twice daily
    Reporting group description
    Participants self-administered oral, active IMP GWP42004, 5 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    GWP42004, 15 mg twice daily
    Reporting group description
    Participants self-administered oral, active IMP GWP42004, 15 mg in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    Placebo, twice daily
    Reporting group description
    Participants self-administered oral placebo in the fasted state, 1 capsule, twice daily, for 12 weeks, approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical to GWP42004 treatment arms.

    Subject analysis set title
    ITT Analysis Set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The ITT analysis set included all randomized participants who took at least 1 dose of IMP and had post-baseline efficacy data.

    Primary: Change From Baseline To The End Of Treatment In Mean Glycosylated Haemoglobin A1c (HbA1c) Level

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    End point title
    Change From Baseline To The End Of Treatment In Mean Glycosylated Haemoglobin A1c (HbA1c) Level
    End point description
    The change from baseline to the end of the 12-week treatment in mean HbA1c levels was analysed for participants with type 2 diabetes following 12 weeks of IMP (GWP42004 or placebo) treatment (or until withdrawal), as an add on to metformin. Analysis of covariance (ANCOVA) was used, with dose included as a categorical variable. Baseline HbA1c was included as a covariate; dose, sex, and centre group were included as factors. Last visit using last observation carried forward (LOCF) was used where appropriate. If a participant in the ITT analysis set had no post-baseline HbA1c levels, baseline observation carried forward (BOCF) was used.
    End point type
    Primary
    End point timeframe
    Baseline, End of Treatment
    End point values
    GWP42004, 2 mg twice daily GWP42004, 5 mg twice daily GWP42004, 15 mg twice daily Placebo, twice daily
    Number of subjects analysed
    52
    53
    52
    48
    Units: percent
        least squares mean (standard error)
    -0.17 ± 0.11
    -0.16 ± 0.11
    -0.22 ± 0.11
    -0.16 ± 0.11
    Statistical analysis title
    GWP42004, 2 mg twice daily versus Placebo
    Comparison groups
    GWP42004, 2 mg twice daily v Placebo, twice daily
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.96
    Method
    ANCOVA
    Parameter type
    Least square mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.29
         upper limit
    0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    GWP42004, 5 mg twice daily versus Placebo
    Comparison groups
    GWP42004, 5 mg twice daily v Placebo, twice daily
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.983
    Method
    ANCOVA
    Parameter type
    Least square mean difference
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.28
         upper limit
    0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14
    Statistical analysis title
    GWP42004, 15 mg twice daily versus Placebo
    Comparison groups
    Placebo, twice daily v GWP42004, 15 mg twice daily
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.677
    Method
    ANCOVA
    Parameter type
    Least square mean difference
    Point estimate
    -0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.34
         upper limit
    0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.14

    Secondary: Change From Baseline To The End Of Treatment In Mean Fasting Plasma Glucose Level

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    End point title
    Change From Baseline To The End Of Treatment In Mean Fasting Plasma Glucose Level
    End point description
    The change from baseline to the end of the 12-week treatment in mean fasting plasma glucose levels was analysed for participants with type 2 diabetes following 12 weeks of IMP (GWP42004 or placebo) treatment (or until withdrawal), as an add on to metformin. Analysis of covariance (ANCOVA) was used, with dose included as a categorical variable. Baseline fasting plasma glucose level was included as a covariate; dose, sex, and centre group were included as factors. Last visit using LOCF was used where appropriate.
    End point type
    Secondary
    End point timeframe
    Baseline, End of Treatment
    End point values
    GWP42004, 2 mg twice daily GWP42004, 5 mg twice daily GWP42004, 15 mg twice daily Placebo, twice daily
    Number of subjects analysed
    52
    53
    52
    48
    Units: millimole/litre
        least squares mean (standard error)
    -0.18 ± 0.27
    -0.02 ± 0.28
    -0.49 ± 0.26
    -0.55 ± 0.28
    No statistical analyses for this end point

    Secondary: Change From Baseline To The End Of Treatment In Mean Serum Fructosamine Levels

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    End point title
    Change From Baseline To The End Of Treatment In Mean Serum Fructosamine Levels
    End point description
    The change from baseline to the end of the 12-week treatment in mean serum fructosamine levels was analysed for participants with type 2 diabetes following 12 weeks of IMP (GWP42004 or placebo) treatment (or until withdrawal), as an add on to metformin. Analysis of covariance (ANCOVA) was used, with dose included as a categorical variable. Baseline serum fructosamine level was included as a covariate; dose, sex, and centre group were included as factors. Last visit using LOCF was used where appropriate.
    End point type
    Secondary
    End point timeframe
    Baseline, End of Treatment
    End point values
    GWP42004, 2 mg twice daily GWP42004, 5 mg twice daily GWP42004, 15 mg twice daily Placebo, twice daily
    Number of subjects analysed
    52
    53
    52
    48
    Units: micromole(s)/litre
        least squares mean (standard error)
    -14.90 ± 5.23
    -8.59 ± 5.24
    -9.65 ± 5.05
    -7.51 ± 5.31
    No statistical analyses for this end point

    Secondary: Change From Baseline To The End Of Treatment In Mean Serum Glucose Levels In The Oral Glucose Tolerance Test [OGTT])

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    End point title
    Change From Baseline To The End Of Treatment In Mean Serum Glucose Levels In The Oral Glucose Tolerance Test [OGTT])
    End point description
    The change from baseline to the end of the 12-week treatment in mean plasma glucose levels 30 minutes and 2 hours post glucose challenge using the OGTT was analysed for participants with type 2 diabetes following 12 weeks of IMP (GWP42004 or placebo) treatment (or until withdrawal), as an add on to metformin. Analysis of covariance (ANCOVA) was used, with dose included as a categorical variable. The baseline value of the respective OGTT parameter was included as a covariate; dose, sex, and centre group were included as factors. Last visit using LOCF was used where appropriate.
    End point type
    Secondary
    End point timeframe
    Baseline, End of Treatment
    End point values
    GWP42004, 2 mg twice daily GWP42004, 5 mg twice daily GWP42004, 15 mg twice daily Placebo, twice daily
    Number of subjects analysed
    52
    53
    52
    48
    Units: millimole(s)/litre
    least squares mean (standard error)
        Glucose Levels After 30 Minutes
    0.84 ± 0.30
    -0.26 ± 0.29
    -0.04 ± 0.29
    0.49 ± 0.31
        Glucose Levels After 120 Minutes
    0.20 ± 0.42
    0.11 ± 0.43
    -0.01 ± 0.42
    0.84 ± 0.46
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening (Visit 1, Day -7) up to the safety follow-up (Day 92)
    Adverse event reporting additional description
    An adverse event (AE) was any new, unintended symptom, diagnosis, or worsening of pre-existing condition presenting between screening and the safety follow-up call that may or may not be related to IMP, or any event that resulted from a trial procedure. Safety analysis set included randomized participants who received at least 1 dose of IMP.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    GWP42004, 2 mg twice daily
    Reporting group description
    Participants self-administered oral, active investigational medicinal product (IMP) GWP42004, 2 mg in the fasted state, twice daily approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    GWP42004, 5 mg twice daily
    Reporting group description
    Participants self-administered oral, active IMP GWP42004, 5 mg in the fasted state, twice daily approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    GWP42004, 15 mg twice daily
    Reporting group description
    Participants self-administered oral, active IMP GWP42004, 15 mg in the fasted state, twice daily approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Reporting group title
    Placebo, twice daily
    Reporting group description
    Participants self-administered oral IMP placebo in the fasted state, twice daily approximately 30 minutes before breakfast and approximately 30 minutes before the evening meal, typically 12 hours apart. The total dose administered within any 24 hour interval was 2 capsules and the number of capsules administered was identical in all arms and at all dose levels.

    Serious adverse events
    GWP42004, 2 mg twice daily GWP42004, 5 mg twice daily GWP42004, 15 mg twice daily Placebo, twice daily
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    1 / 48 (2.08%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 53 (0.00%)
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer haemorrhage
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 53 (0.00%)
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    GWP42004, 2 mg twice daily GWP42004, 5 mg twice daily GWP42004, 15 mg twice daily Placebo, twice daily
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 54 (9.26%)
    4 / 53 (7.55%)
    2 / 52 (3.85%)
    9 / 48 (18.75%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 54 (5.56%)
    2 / 53 (3.77%)
    1 / 52 (1.92%)
    2 / 48 (4.17%)
         occurrences all number
    3
    3
    1
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 53 (3.77%)
    1 / 52 (1.92%)
    4 / 48 (8.33%)
         occurrences all number
    1
    2
    1
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 54 (1.85%)
    2 / 53 (3.77%)
    0 / 52 (0.00%)
    4 / 48 (8.33%)
         occurrences all number
    1
    2
    0
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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