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    Clinical Trial Results:
    A Phase II study in patients with locally advanced pancreatic carcinoma: ARC-II – Akt-inhibition by Nelfinavir plus chemoradiation with gemcitabine and cisplatin

    Summary
    EudraCT number
    2008-006302-42
    Trial protocol
    GB  
    Global end of trial date
    27 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    08 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    309/H0604/36
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Clinical Trials & Research Governance, University Oxford
    Sponsor organisation address
    Churchill Hospital Headington, Oxford, United Kingdom, OX3 7LE
    Public contact
    Somnath Mukherjee, Early Phase Research Hub (ARC II), 44 1865235302, earlyphasehub@oncology.ox.ac.uk
    Scientific contact
    Somnath Mukherjee, Early Phase Research Hub (ARC II), 44 1865235302, earlyphasehub@oncology.ox.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
    05 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess if the addition of nelfinavir to gemcitabine and cisplatin chemoradiotherapy improves survival and merits further study.
    Protection of trial subjects
    The trial received ethical and regulatory approval, and was run in compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004, and amendments thereafter, the guidelines for Good Clinical Practice, and the applicable policies of the Sponsor, the University of Oxford. Together, these regulations implement the ethical principles of the Declaration of Helsinki (2008) and the regulatory requirements for clinical trials of an investigational medicinal product as set out in the European Union (EU) Directives 001/20/EC (Clinical Trials) and 2005/28/EC (GCP). Standard phase II cancer clinical trial methodology using an agent with a very well known toxicity profile in an unlicensed indication. Subjects were monitored closely for toxicity.
    Background therapy
    Gemcitabine and cisplatin chemoradiotherapy (CRT). Radiotherapy is delivered daily (Monday to Friday). The total dose is 50.4 Gy in 28# (1.8Gy/#) to the elective regional lymph nodes and 59.4 Gy in 33# (1.8Gy/#) to the primary tumour. The first day of radiotherapy should be a Monday (day 1) if feasible but flexibility of ±1 day is allowed. Gemcitabine is administered IV at 300 mg/m² BSA on days 2, 9, 23, and 30 (corresponding to Tuesday of the 1st, 2nd, 4th and 5th week of radiotherapy) where feasible but flexibility of ±1 day is allowed. Cisplatin is administered IV at 30 mg/m² BSA on days 2, 9, 23, and 30 (corresponding to Tuesday of the 1st, 2nd, 4th and 5th week of radiotherapy) where feasible but flexibility of ±1 day is allowed. Radiotherapy should be given within one hour of completing the cisplatin infusion.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    07 Dec 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy, Scientific research
    Long term follow-up duration
    12 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    11
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Trial recruited from a single UK centre between 02Dec2009 and 15 Jul2014. First patient was recruited 18Jan2010.

    Pre-assignment
    Screening details
    In total 39 patients were screened. Sixteen (16) were excluded. Of these 10 were not eligible and six declined.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Overall trial
    Arm description
    Overall trial (Single arm)
    Arm type
    Experimental

    Investigational medicinal product name
    Nelfinavir mesotheliate
    Investigational medicinal product code
    Other name
    VIRACEPT®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally at a dose of 1250mg bd on Days -8 to 45 (this corresponds to five 250mg tablets in the morning and five 250mg tablets in the evening

    Number of subjects in period 1
    Overall trial
    Started
    23
    Received study intervention
    23
    Completed 12 month follow-up
    22
    Completed
    22
    Not completed
    1
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    23 23
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    10 10
        From 65-84 years
    13 13
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    10 10
        Male
    13 13
    Karnofsky Performance Status
    Units: Subjects
        >80
    15 15
        70-80
    7 7
        Not recorded
    1 1

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    Overall trial (Single arm)

    Primary: Proportion of subjects surviving to 12 months after trial entry

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    End point title
    Proportion of subjects surviving to 12 months after trial entry [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 months after trial entry
    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: This is a single arm, non-comparative study. EudraCT – Results Webinar 27 January 2016 advises: Q2: unable to upload stats for one analysis group when this will be implemented and what to do meantime? A2: if the trial includes only one arm or one reporting group, results can be prepared and endpoints can be reported upon for this reporting group/arm. The statistical analysis being optional.
    End point values
    Overall trial
    Number of subjects analysed
    23
    Units: Patients
    number (confidence interval 90%)
        Alive at 12 months
    73.4 (54.5 to 85.5)
    No statistical analyses for this end point

    Secondary: Progression Free Survival at 12 months

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    End point title
    Progression Free Survival at 12 months
    End point description
    End point type
    Secondary
    End point timeframe
    12 months after entry on trial
    End point values
    Overall trial
    Number of subjects analysed
    19 [2]
    Units: Subjects
        Progression free
    12
        Progressive disease
    7
    Notes
    [2] - None evaluable: 2 died prior to 12 months, 1 did not complete treatment, 1 died at end of treatment.
    No statistical analyses for this end point

    Secondary: Resectability after primary non-resectability

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    End point title
    Resectability after primary non-resectability
    End point description
    Result of restaging investigations following treatment with nelfinavir and chemo-radiotherapy.
    End point type
    Secondary
    End point timeframe
    6-8 weeks after completion of chemo-radiotherapy
    End point values
    Overall trial
    Number of subjects analysed
    21 [3]
    Units: Subjects
        Resectable
    2
        Not resectable
    19
    Notes
    [3] - 2 died before restaging
    No statistical analyses for this end point

    Secondary: Site of treatment failure/ first progression

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    End point title
    Site of treatment failure/ first progression
    End point description
    Loco-regional progression within radiotherapy treatment field vs distant progression outside the treatment field
    End point type
    Secondary
    End point timeframe
    Overall time to progression
    End point values
    Overall trial
    Number of subjects analysed
    19
    Units: subjects
        Loco-regional progression
    4
        Distant progression
    15
    No statistical analyses for this end point

    Secondary: Objective response (RECIST)

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    End point title
    Objective response (RECIST)
    End point description
    End point type
    Secondary
    End point timeframe
    Restaging 6-8 weeks after end of chemo-radiotherapy
    End point values
    Overall trial
    Number of subjects analysed
    21 [4]
    Units: subjects
        Complete response
    0
        Partial response
    5
        Stable disease
    10
        Progressive disease
    6
    Notes
    [4] - Two died before restaging
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of treatment to 28 days post end of treatment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    Overall trial (Single arm)

    Serious adverse events
    Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 23 (65.22%)
         number of deaths (all causes)
    19
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Thromboembolic event
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    fall- cut above right eye and graze on the right cheek
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Decreased lymphocytes
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Increased bilirubin
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Confusion of unknown cause
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Extravasation of F-MISO Dye
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
    Additional description: Probably related to radiotherapy
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 23 (17.39%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    4 / 23 (17.39%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Rectal bleeding
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 23 (95.65%)
    Vascular disorders
    Splenic vein thrombosis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Bleeding PICC line exit
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Investigations
    Decreased CD4 lymphocytes
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Decreased lymphocytes
         subjects affected / exposed
    19 / 23 (82.61%)
         occurrences all number
    48
    Decreased neutrophils
         subjects affected / exposed
    8 / 23 (34.78%)
         occurrences all number
    14
    Decreased white blood cells
         subjects affected / exposed
    8 / 23 (34.78%)
         occurrences all number
    15
    Elevated alkaline Phosphatase
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    5
    Increased ALT
         subjects affected / exposed
    5 / 23 (21.74%)
         occurrences all number
    8
    Increased AST
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    2
    Increased bilirubin
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    7
    Increased GGT
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Abnormal LFTs
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Thrombocytopenia
         subjects affected / exposed
    16 / 23 (69.57%)
         occurrences all number
    26
    Weight loss diet
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 23 (52.17%)
         occurrences all number
    14
    Nervous system disorders
    Anxiety and confusion
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Drowsiness
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    Dysarthria
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Dysgeusia
    Additional description: Loss of taste
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Seizure
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Syncope
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Tremor
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Eye disorders
    Blurred vision
    Additional description: Visual disturbance
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    16 / 23 (69.57%)
         occurrences all number
    35
    Fever
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Flu-like symptoms
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 23 (21.74%)
         occurrences all number
    7
    Anorexia
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    4
    Constipation
         subjects affected / exposed
    6 / 23 (26.09%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    16 / 23 (69.57%)
         occurrences all number
    30
    Distended abdomen
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Diverticulitis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Faecal incontinence
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Gastritis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Gastro-oesophageal reflux
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Haematemesis
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    18 / 23 (78.26%)
         occurrences all number
    37
    Pancreatic enzymes decreased
    Additional description: Steatorrhea
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    11 / 23 (47.83%)
         occurrences all number
    28
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Skin rash
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperglycemia
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    3
    Hypoglycaemia
    Additional description: Hypoglycemic episode
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Hypokalemia
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    3
    Hypomagnesaemia
         subjects affected / exposed
    3 / 23 (13.04%)
         occurrences all number
    3
    Hyponatraemia
         subjects affected / exposed
    6 / 23 (26.09%)
         occurrences all number
    9
    Infections and infestations
    Oral candidiasis
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2
    Sepsis
    Additional description: One Neutropenic sepsis and the other pneumonia
         subjects affected / exposed
    2 / 23 (8.70%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Oct 2010
    Extensive revision of protocol formatting and wording throughout to improve brevity and clarity without changing the original clinical or scientific intent of the authors. Addition of the Oxford University Oncology Clinical Trials Office (OCTO) for coordination of the multicentre trial . Intention to follow patients for overall survival added as a secondary endpoint intention to look for a correlation of response in imaging and response in histopathology in resected patients added as a new secondary endpoint Clarification that examining the effect of nelfinavir treatment on phospho-Akt expression is an exploratory objective. Addition of Radiotherapy Quality Assurance. For safety reasons random glucose will be monitored in blood tests taken while patient is receiving nelfinavir as there is a small increased risk of diabetes. Research blood samples increased from 30ml at 2 time points to a total 70ml per patient to 35ml on 7 occasions (screen, wks 2, 3, 4, 5,6,7,) to a total of 245ml per patient; Reduced duration of formal trial follow-up visits to 12 months post CRT (patients will be seen in trial clinics for ~14 months). Added clarification of intent to follow-up all patients longer term as necessary to record progression free survival and overall survival; Addition of optional collection of surplus formalin fixed tissue from routine diagnostic biopsy and surgery. Classify routine, planned hospital admissions for supportive care or social reasons as SAEs which do not require immediate reporting. Require reports to be submitted in the case of pregnancies (in a trial subject or subject’s partner). The ‘end of trial’ is defined as 18 months after enrolment of the last patient into the trial. Increase participating Centres New information on contra-indications given in current SmPC for nelfinavir (Viricept) dated 08Feb10 incorporated into Protocol Changes to patient information sheet and GP letter
    18 Dec 2012
    Change of Chief Investigator Addition of a functional imaging cohort and associated secondary and exploratory endpoint measures Additional research blood sampling at functional imaging timepoints Obtain pre-screening consent for 18F-FDG-PET scan to exclude distant metastases prior to main trial screening Increase duration of nelfinavir induction from 3 to 9 days prior to start of background chemo-radiotherapy Minor administrative changes

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    16 Aug 2011
    Temporary halt to recruitment to ARC II for administrative reasons. Recruitment put on hold pending production, submission and approval of a substantial amendment. That will enable the study to re-open as a single centre (Oxford only) trial that incorporates a functional imaging component. The number of participants will be reduced and primary end point of the trial will be amended in light of recent new studies on a similar theme. 2. To facilitate an agreed transfer of responsibility for coordination from the Oxford Oncology Clinical Trials Office (OCTO) which specialises in the conduct of multicentre trials to the Early Phase Hub, an administratively separate team within Oncology which specialises in smaller translational trials. 3. Making the trial single centre enables the integration of a functional imaging component that will enhance the scientific importance of the study. We wish to maximise the number of patients recruited into the imaging cohort. 4. The trial has recruited well in Oxford to date and remains viable as a single centre study. There is considerable interest and support elsewhere and It is hoped that ARC II will lead into to a nationally adopted larger scale study. Hence the scientific and clinical importance of the protocol is not affected. 5. The Sponsor and Early Phase Hub agreed to put recruitment on hold in order to ensure there is an orderly transfer from OCTO. The temporary halt will allow time for the protocol amendment to be written and a backlog of monitoring and data collection cleared. 6. An initial monitoring visit conducted by the Sponsor (10th August 2011) to assess the current situation at the study site did not raise any major concerns over the safety and rights of participants, the overall risk benefit assessment of the investigational medicinal product or the scientific value of the trial.
    13 Jan 2012

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study had several shortcomings. It was not randomised, recruitment was difficult resulting in a lack of power to address the primary endpoint. So the promising outcome from the trial needs to be interpreted with caution.

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/27117177
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