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    Clinical Trial Results:
    The Relationship between Osteoporosis and Aortic Calcification in Postmenopausal Women

    Summary
    EudraCT number
    		 2008-001865-28
    Trial protocol
    		 GB  
    Global end of trial date
    24 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2018
    First version publication date
    08 Nov 2018
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    08/H0802/9
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Osteoporosis Unit , King's College London, 0044 207 1887188,
    Scientific contact
    Osteoporosis Unit , King's College London, 0044 207 1887188,
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Osteoporosis Unit, King's College London, 0044 2071887188, michelle.frost@kcl.ac.uk
    Scientific contact
    Osteoporosis Unit, King's College London, 0044 2071887188, michelle.frost@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
    24 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia.
    Protection of trial subjects
    Informed consent will be obtained before any screening procedures are performed
    Background therapy
    		 None
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2008
    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
    United Kingdom: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    20
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Thirty subjects were recruited on to this part of the study, although 6 subjects failed at screening. Study subjects were randomised and divided into two groups. Participants were recruited from one clinical site in London.

    Pre-assignment
    Screening details
    		 inclusion criteria:  Ambulatory postmenopausal* women  Aged 50 years and over  Lumbar spine (L1-L4) and/or femoral neck and/or total hip BMD measurement more than 2 standard deviations below the young adult mean for healthy women (T-score ≤ -2).  Normal or clinically insignificant laboratory values

    Period 1
    Period 1 title
    Whole Group (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open label trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Interventional
    Arm description
    		 Once weekly alendronate 70mg for 2-years and daily calcium and vitamin D supplementation providing 600mg/400IU of calcium and vitamin D.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alendronic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once weekly alendronate 70mg for 2-years and daily calcium and vitamin D supplementation providing 600mg/400IU of calcium and vitamin D

    Investigational medicinal product name
    Calcium & Vitamin D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    daily calcium and vitamin D supplementation providing 600mg/400IU of calcium and vitamin D..

    Arm title
    		 Control Group
    Arm description
    		 Participants prescribed calcium and vitamin D supplements providing 600mg/400IU of calcium and vitamin D
    Arm type
    		 CONTROL

    Investigational medicinal product name
    calcium and vitamin D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    12 controls that were only given calcium and vitamin D supplements providing 600mg/400IU of calcium and vitamin D. The study subjects attended for a total of 7 visits over 2-years.

    Number of subjects in period 1
    		Interventional Control Group
    Started
    14
    12
    Completed
    12
    10
    Not completed
    2
    2
         Lost to follow-up
    2
    2

    Baseline characteristics

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    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Interventional
    Reporting group description
    		 Once weekly alendronate 70mg for 2-years and daily calcium and vitamin D supplementation providing 600mg/400IU of calcium and vitamin D.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants prescribed calcium and vitamin D supplements providing 600mg/400IU of calcium and vitamin D

    Primary: Clinical Endpoint

    		 Close Top of page
    End point title
    		 Clinical Endpoint [1]
    End point description
    To evaluate the effects of bisphosphonate alendronate on aortic calcification in postmenopausal women with osteoporosis and severe osteopenia
    End point type
    Primary
    End point timeframe
    Duration of the trial
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see attached report for full results.
    End point values
    		 Interventional Control Group
    Number of subjects analysed
    12
    10
    Units: whole
    12
    10
    No statistical analyses for this end point

    Secondary: Clinical Endpoint

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    End point title
    		 Clinical Endpoint
    End point description
    To examine the relationship between BMD and aortic calcification
    End point type
    Secondary
    End point timeframe
    Duration of trial
    End point values
    		 Interventional Control Group
    Number of subjects analysed
    12
    10
    Units: whole
    12
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Duration of Trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Interventional Arm
    Reporting group description
    		 -

    Reporting group title
    Control Arm
    Reporting group description
    		 -

    Serious adverse events
    		 Interventional Arm Control Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Interventional Arm Control Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    9 / 10 (90.00%)
    Surgical and medical procedures
    Angiogram
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Cholesytectomy & gall stones removed
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Colonoscopy
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Crown replacement
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Curettage
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Filling
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Hip replacement
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Removal of papilloma from buttock
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Removal of right ingrown eyelash
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    Retinal attachment operation
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Root canal
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Dental examination abnormal
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Tooth implant
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    General malaise
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Tooth ache
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Reproductive system and breast disorders
    Vaginal atrophy
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Recurrence of post-menopausal bleed
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Fibroids
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Apical pleural thickening
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Breathlessness (climbing stairs)
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Cold
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Dyspnoea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Fever/coughing/general malaise
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Inflammatory lung nodule
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Loss of voice
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Parenchymal lung nodule
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Peripheral lung nodule
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Pleural effusion
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Pleural nodularity in lung bases
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Precordial tightness
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Recurence of asthma
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Retroperitoneal calcification to Hilium
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Small peripheral lung nodule
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Sore throat
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    4
    1
    Thoracic pleural thickening
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 12 (33.33%)
    2 / 10 (20.00%)
         occurrences all number
    7
    3
    Wheezing and coughin
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Mild depression/low mood
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Food poisoning
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 10 (20.00%)
         occurrences all number
    2
    2
    Migraine
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Bilateral axillary adenopathy
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Mild lymphocytic lymphoma/CLL
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Possible lymph nodes sternoclavicular
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Calcification at splenic hilum
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Mediastinal adenopathy
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Adenopathy with mesenteric stranding
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Thickness in ear
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision loss
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Increase in ophthalmic pressure
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Eye pain/irritation
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Acid reflux & oesophageal discomfort
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Bloating of abdomen
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Indigestion
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Nausea
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Norovirus
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Stomach pain
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 10 (20.00%)
         occurrences all number
    1
    7
    Gastric Upset
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    3
    Hepatobiliary disorders
    Liver cysts
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gallstones
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Insect bites on leg
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urinary Tract infection
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 10 (10.00%)
         occurrences all number
    12
    2
    Renal calculus
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Urinary incontinence when walking fast
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Thyroid nodule
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Adrenal adenoma
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    3 / 12 (25.00%)
    1 / 10 (10.00%)
         occurrences all number
    4
    1
    Broken rib
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Chest pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Cold fingertips
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Broken finger
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Fractured metatarsal in foot
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Grade 1 anterolisthesis of L5 on S1
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Frozen shoulder
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Hip Pain
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Increase in stiffness (knees/ankle)
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Intervertebral height loss
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    2
    Loss of joint space at hip
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Multi-focal end plate thickening
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Painful knee
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Joint pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Painful shoulder
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Painful thumb joint
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Paresthesia in scapula
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Rib pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Shortening of left leg length
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Shoulder and neck pain
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Shoulder pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Tennis elbow
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vertebral body degeneration
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Genital Herpes
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Endobronchial infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Oct 2009
    Change of Chief Investigator and classification of part of this trial.
    19 Jan 2012
    Amendment to protocol sample size from 50 to 26 participants

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    25 Aug 2009
    Change of Chief Investigator and classification of part of the trial
    14 Oct 2009

    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/27572995
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