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    Clinical Trial Results:
    Bone Evaluation in HIV-positive women over 40 who Switch from TDF + 3TC/FTC + NNRTI to Triumeq

    Summary
    EudraCT number
    		 2015-005297-37
    Trial protocol
    		 GB  
    Global end of trial date
    14 Feb 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions
    Summary report(s)
    		 Clinical Study report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    3552
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Dr Frank Post, King's College Hospital NHS Foundation Trust, 0044 20784857795776, frank.post@kcl.ac.uk
    Scientific contact
    Dr Frank Post, King's College Hospital NHS Foundation Trust, 0044 20784857795776, frank.post@kcl.ac.uk
    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
    28 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Feb 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to compare the changes in bone mineral density (BMD) over 96 weeks in women who switch from Truvada/NNRTI to Triumeq, as compared to women who stay on their current Truvada/NNRTI regimen.
    Protection of trial subjects
    Patients are free to withdraw consent for study treatment and/or consent to participate in the study at any time and without the prejudice to further treatment. Patients who withdraw from study treatment, but are willing to continue to participate in the follow-up visits, should be followed according to the procedures outlined in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 91
    Worldwide total number of subjects
    91
    EEA total number of subjects
    91
    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)
    87
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 HIV positive women ≥40 years on stable antiretroviral therapy consisting of TDF/ FTC (or 3TC) plus an NNRTI with HIV RNA <50 copies/mL for at least 12 months will be eligible to enter the trial.

    Pre-assignment period milestones
    Number of subjects started
    		 102 [1]
    Number of subjects completed
    		 91

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 screen fail: 11
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The pre-assignment period includes participants who were screened and then not enrolled into the study
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Switch ABC/3TC/DTG
    Arm description
    		 Switch to Triumeq (abacavir 600 mg, lamivudine 300 mg, dolutegravir 50 mg), one tablet daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Triumeq
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: 600mg abacavir, 300mg lamivudine, 50mg dolutegravir Daily dose: 1 tablet Duration of use: 96 weeks

    Arm title
    		 Ongoing TDF/FTC/NNRTI
    Arm description
    		 Participants who are randomised to arm 2 will continue on their current antiretroviral therapy. This will contain tenofovir disoproxil fumarate, emtricitabine or lamivudine, and an NNRTI (nevirapine, efavirenz, etravirine, rilpivirine), administered singularly or as a fixed dose combination. Fixed dose combinations include Atripla, Eviplera or Truvada plus an NNRTI.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: 245mg tenofovir disoproxil fumarate Daily dose: 1 tablet once daily Duration of use: 96 weeks

    Investigational medicinal product name
    Lamivudine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: 150mg lamivudine or 300mg lamivudine Daily dose: 300mg daily Duration of use: 96 weeks

    Investigational medicinal product name
    Truvada
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: 245mg tenofovir disoproxil fumarate, 200mg emtricitabine Daily dose: 1 tablet Duration of use: 96 weeks

    Investigational medicinal product name
    Atripla
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: Efavirenz 600mg, emtricitabine 200mg, tenofovir disoproxil fumarate 245mg Daily dose: 1 tablet Duration of use: 96 weeks

    Investigational medicinal product name
    Eviplera
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: Rilpivirine 25mg, emtricitabine 200mg, tenofovir disoproxil fumarate 245mg Daily dose: 1 tablet Duration of use: 96 weeks

    Investigational medicinal product name
    Efavirenz
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: Efavirenz 600mg tablet or 200mg capsule Daily dose: 600mg Duration of use: 96 weeks

    Investigational medicinal product name
    Nevirapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: Nevirapine 400mg prolonged release (PR) or 200mg tablet Daily dose: 400mg Duration of use: 96 weeks

    Investigational medicinal product name
    Etravirine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: 200mg Daily dose: Etravirine 400mg Duration of use: 96 weeks

    Investigational medicinal product name
    Rilpivirine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Unit strength: Rilpivirine 25mg Daily dose: 25mg Duration of use: 96 weeks

    Number of subjects in period 1
    		Switch ABC/3TC/DTG Ongoing TDF/FTC/NNRTI
    Started
    59
    32
    Completed
    59
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Switch ABC/3TC/DTG
    Reporting group description
    		 Switch to Triumeq (abacavir 600 mg, lamivudine 300 mg, dolutegravir 50 mg), one tablet daily

    Reporting group title
    Ongoing TDF/FTC/NNRTI
    Reporting group description
    		 Participants who are randomised to arm 2 will continue on their current antiretroviral therapy. This will contain tenofovir disoproxil fumarate, emtricitabine or lamivudine, and an NNRTI (nevirapine, efavirenz, etravirine, rilpivirine), administered singularly or as a fixed dose combination. Fixed dose combinations include Atripla, Eviplera or Truvada plus an NNRTI.

    Reporting group values
    		 Switch ABC/3TC/DTG Ongoing TDF/FTC/NNRTI Total
    Number of subjects
    		 59 32 91
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.9 ± 7.0 49.5 ± 6.0 -
    Gender categorical
    Units: Subjects
        Female
    		 59 32 91
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Switch ABC/3TC/DTG
    Reporting group description
    		 Switch to Triumeq (abacavir 600 mg, lamivudine 300 mg, dolutegravir 50 mg), one tablet daily

    Reporting group title
    Ongoing TDF/FTC/NNRTI
    Reporting group description
    		 Participants who are randomised to arm 2 will continue on their current antiretroviral therapy. This will contain tenofovir disoproxil fumarate, emtricitabine or lamivudine, and an NNRTI (nevirapine, efavirenz, etravirine, rilpivirine), administered singularly or as a fixed dose combination. Fixed dose combinations include Atripla, Eviplera or Truvada plus an NNRTI.

    Primary: • Between study-arm changes from baseline in total hip bone mineral density (BMD) at week 48

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    End point title
    		 • Between study-arm changes from baseline in total hip bone mineral density (BMD) at week 48
    End point description
    End point type
    Primary
    End point timeframe
    baseline to week 96
    End point values
    		 Switch ABC/3TC/DTG Ongoing TDF/FTC/NNRTI
    Number of subjects analysed
    59
    32
    Units: g/cm2
    median (full range (min-max))
        Baseline
    0.96 (0.92 to 0.99)
    1.03 (0.98 to 1.08)
        Week 96
    0.96 (0.93 to 1.00)
    1.02 (0.98 to 1.07)
    Statistical analysis title
    		 Adjusted mean difference between study arms
    Statistical analysis description
    Intention to treat analyses.
    Comparison groups
    Switch ABC/3TC/DTG v Ongoing TDF/FTC/NNRTI
    Number of subjects included in analysis
    91
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.438
    Method
    		 Regression, Linear
    Confidence interval
    Notes
    [1] - Intention to treat

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    baseline to week 96
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Switch ABC/3TC/DTG
    Reporting group description
    		 Switch to Triumeq (abacavir 600 mg, lamivudine 300 mg, dolutegravir 50 mg), one tablet daily

    Reporting group title
    Ongoing TDF/FTC/NNRTI
    Reporting group description
    		 Participants who are randomised to arm 2 will continue on their current antiretroviral therapy. This will contain tenofovir disoproxil fumarate, emtricitabine or lamivudine, and an NNRTI (nevirapine, efavirenz, etravirine, rilpivirine), administered singularly or as a fixed dose combination. Fixed dose combinations include Atripla, Eviplera or Truvada plus an NNRTI.

    Serious adverse events
    		 Switch ABC/3TC/DTG Ongoing TDF/FTC/NNRTI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 59 (15.25%)
    2 / 32 (6.25%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Hysterectomy
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    perianal abscess
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Attempted suicide
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    papillary carcinoma
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Mixed connective tissue disease
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Switch ABC/3TC/DTG Ongoing TDF/FTC/NNRTI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 59 (88.14%)
    25 / 32 (78.13%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Hypothyroidism
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Abnormal dreams
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 32 (0.00%)
         occurrences all number
    3
    0
    Insomnia
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 32 (0.00%)
         occurrences all number
    4
    0
    Parasomnia
         subjects affected / exposed
    4 / 59 (6.78%)
    0 / 32 (0.00%)
         occurrences all number
    4
    0
    Immune system disorders
    allergic reaction
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    2
    Anaemia
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    folic acid deficiency
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    hayfever
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 32 (0.00%)
         occurrences all number
    3
    0
    low b12 and folate
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 32 (3.13%)
         occurrences all number
    5
    1
    Reproductive system and breast disorders
    Adnexal mass
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    bulky uterus
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Endometrial thickening
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    fibroids
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    menorrhagia
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Postmenopausal bleeding
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    vaginal bleeding
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    vaginal candidasis
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    chest infection
         subjects affected / exposed
    3 / 59 (5.08%)
    2 / 32 (6.25%)
         occurrences all number
    3
    2
    cold/coryzal symptoms
         subjects affected / exposed
    5 / 59 (8.47%)
    6 / 32 (18.75%)
         occurrences all number
    5
    6
    Cough
         subjects affected / exposed
    9 / 59 (15.25%)
    2 / 32 (6.25%)
         occurrences all number
    10
    2
    post nasal drip
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Throat irritation
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 32 (3.13%)
         occurrences all number
    3
    1
    Sinusitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Depression
         subjects affected / exposed
    0 / 59 (0.00%)
    2 / 32 (6.25%)
         occurrences all number
    0
    2
    suicidal thoughts
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    low mood
         subjects affected / exposed
    4 / 59 (6.78%)
    3 / 32 (9.38%)
         occurrences all number
    4
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 59 (8.47%)
    3 / 32 (9.38%)
         occurrences all number
    5
    3
    Fatigue
         subjects affected / exposed
    5 / 59 (8.47%)
    2 / 32 (6.25%)
         occurrences all number
    5
    2
    Headache
         subjects affected / exposed
    4 / 59 (6.78%)
    2 / 32 (6.25%)
         occurrences all number
    4
    2
    Migraine
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    neurocognitive symptoms
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Memory impairment
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Blepharitis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    itchy eyes
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    bilateral red eyelids
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Dry eye
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    sty
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Toothache
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    root canal
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    Tooth erosion
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    abdominal heat
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Diarrhoea
         subjects affected / exposed
    5 / 59 (8.47%)
    2 / 32 (6.25%)
         occurrences all number
    6
    3
    Dyspepsia
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    1 / 59 (1.69%)
    14 / 32 (43.75%)
         occurrences all number
    1
    1
    reflux
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    stomach pain
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 32 (0.00%)
         occurrences all number
    3
    0
    Vomiting
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Abscess
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    localised rash
         subjects affected / exposed
    4 / 59 (6.78%)
    1 / 32 (3.13%)
         occurrences all number
    4
    1
    athletes foot
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    coldsores
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    darkened patches
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Skin infection
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Swollen finger
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    haemarrhoids
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Hot flush
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    infected hair follicle
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Wound infection
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    itchiness
         subjects affected / exposed
    4 / 59 (6.78%)
    0 / 32 (0.00%)
         occurrences all number
    4
    0
    Lichen planus
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Lipodystrophy
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    shoulder lump
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Skin lesion
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    solar keratosis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Kidney infection
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 59 (3.39%)
    2 / 32 (6.25%)
         occurrences all number
    2
    2
    Micturition difficulty
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Weight increased
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 32 (0.00%)
         occurrences all number
    4
    0
    body pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    painful ankles
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    arm pain
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    Back pain
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    lower back muscle spasm
         subjects affected / exposed
    0 / 59 (0.00%)
    15 / 32 (46.88%)
         occurrences all number
    0
    1
    body aches
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    early changes of degeneration in spine
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    golfer's elbow
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    hip pain
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    insertional tendinopathy
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    intermittent bilateral bony elbow pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    jaw pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    joint pain
         subjects affected / exposed
    1 / 59 (1.69%)
    2 / 32 (6.25%)
         occurrences all number
    1
    2
    knee/ankle pain
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    leg pain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    medial epicondylitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    neck strain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Rheumatoid arthritis/osteoarthritis
         subjects affected / exposed
    1 / 59 (1.69%)
    1 / 32 (3.13%)
         occurrences all number
    1
    1
    right glutal tendonitis
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    medial foot pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Sciatic nerve pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    shoulder pain
         subjects affected / exposed
    5 / 59 (8.47%)
    1 / 32 (3.13%)
         occurrences all number
    5
    1
    finger stiffness
         subjects affected / exposed
    2 / 59 (3.39%)
    0 / 32 (0.00%)
         occurrences all number
    2
    0
    thigh pain
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    tingling in arms and legs
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    weak joints
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    ankle oedema
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    burn
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    banged knee
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    enlarged heart
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    left leg weakness
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    finger cut
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    left foot injury
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    face pain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1
    Infections and infestations
    ear pain
         subjects affected / exposed
    2 / 59 (3.39%)
    1 / 32 (3.13%)
         occurrences all number
    2
    1
    fever
         subjects affected / exposed
    1 / 59 (1.69%)
    0 / 32 (0.00%)
         occurrences all number
    1
    0
    Influenza
         subjects affected / exposed
    5 / 59 (8.47%)
    0 / 32 (0.00%)
         occurrences all number
    5
    0
    respiratory infection
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 32 (0.00%)
         occurrences all number
    3
    0
    Metabolism and nutrition disorders
    Anorexia nervosa
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 32 (3.13%)
         occurrences all number
    0
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32985122
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