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    Clinical Trial Results:
    A randomised controlled trial of eicosapentaenoic acid (EPA) and/or aspirin for colorectal adenoma (or polyp) prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme: The seAFOod (Systematic Evaluation of Aspirin and Fish Oil) polyp prevention trial.

    Summary
    EudraCT number
    2010-020943-10
    Trial protocol
    GB  
    Global end of trial date
    12 Jun 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Jan 2020
    First version publication date
    22 Jan 2020
    Other versions
    Summary report(s)
    primary trial publication - The Lancet 2018
    primary publication - supplementary material
    seAFOod Trial - NIHR Journals article

    Trial information

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    Trial identification
    Sponsor protocol code
    GA10/9312
    Additional study identifiers
    ISRCTN number
    ISRCTN05926847
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Worsley Building, Leeds, United Kingdom, LS2 9JT
    Public contact
    Professor Mark Hull, Professor of Molecular Gastroenterology, Leeds Institute of Medical Research, University of Leeds, 0113 3438650, M.A.Hull@leeds.ac.uk
    Scientific contact
    Professor Mark Hull, Professor of Molecular Gastroenterology, Leeds Institute of Medical Research, University of Leeds, 0113 3438650, M.A.Hull@leeds.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
    12 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the naturally-occurring omega (ω)-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA) prevents colorectal adenomas, either alone or in combination with aspirin.
    Protection of trial subjects
    This clinical trial, which involved the use investigational medicinal products (IMPs) was designed and was be run in accordance with the Principles of GCP and the current regulatory requirements, as detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK Statutory Instrument (S.I.) 2004 / 1031) and any subsequent amendments of the Clinical Trial Regulations. The seAFOod trial was monitored by the Sponsor to assess this. The trial used both a TSC and DMC. The eligibility criteria were robust and were approved by both the MHRA & a Research Ethics Committee.
    Background therapy
    Trial participants all underwent a screening and surveillance colonoscopy as part of the English Bowel cancer Screening Programme.
    Evidence for comparator
    The comparator for EPA and aspirin was a placebo, justified on the basis that there is no strong evidence for use of either agent for colorectal cancer (CRC) prevention and neither agent is used in best clinical practice. The intervention lasted for only 12 months, which is much shorter than the natural history of CRC development, as was followed by a colonoscopy. Therefore, there was deemed to be little if any harm associated with takingplacebo rather than active IMPs.
    Actual start date of recruitment
    14 Oct 2011
    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: 707
    Worldwide total number of subjects
    707
    EEA total number of subjects
    707
    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)
    348
    From 65 to 84 years
    359
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients aged 55-73 who had undergone a screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP) were recruited between November 2011 and June 2016 from 53 english NHS hospital endoscopy units.

    Pre-assignment
    Screening details
    3911 individuals, who were classified as 'high risk' (greater than/equal to 3 colorectal adenomas if one was greater than/equal to 10 mm in size; or 5 colorectal adenomas of any size) on the basis of the BCSP screening colonoscopy, were screened for eligibility. 3202 (82%) were not randomised (2179 ineligible and 1023 unwilling to take part)

    Period 1
    Period 1 title
    intervention trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    There were identical placebos for the capsule and tablet IMPs. The sequence of treatment allocations was concealed until recruitment, data collection, and database lock were completed. Investigational Medicinal Product (IMP) allocation was not divulged to any research staff or participant.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Eicosapentaenoic acid (EPA)
    Arm description
    EPA alone
    Arm type
    Experimental

    Investigational medicinal product name
    eicosapentaenoic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    99% EPA-FFA 2 g daily (as two 500 mg gastro-resistant capsules twice daily with food) or an equivalent FFA dose as 90% EPA-triglyceride (TG) 2780 mg daily (as five soft-gelatin capsules per day split over two meals

    Arm title
    aspirin
    Arm description
    aspirin alone
    Arm type
    Experimental

    Investigational medicinal product name
    aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    enteric-coated aspirin 300 mg tablet daily with food

    Arm title
    EPA + aspirin
    Arm description
    Combined EPA and aspirin
    Arm type
    Experimental

    Investigational medicinal product name
    EPA capsules and aspirin tablet combined as in active agent alone arms
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Identical dosage and administration of EPA capsules and aspirin tablet as single agent arms

    Arm title
    placebo
    Arm description
    Double (capsule and tablet) placebo
    Arm type
    Placebo

    Investigational medicinal product name
    capsule placebo (capric and capryllic acid) and tablet placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Identical administration to active capsule (EPA) and active tablet (aspirin) arm

    Number of subjects in period 1
    Eicosapentaenoic acid (EPA) aspirin EPA + aspirin placebo
    Started
    178
    176
    177
    176
    Completed
    154
    163
    161
    163
    Not completed
    24
    13
    16
    13
         various
    4
    -
    2
    1
         reason missing
    -
    -
    1
    -
         required more than one rpt colonoscopy
    -
    4
    -
    -
         Adverse event, serious fatal
    -
    -
    -
    1
         Adverse event, non-fatal
    1
    1
    2
    1
         Consent withdrawn by subject
    12
    5
    7
    8
         Lost to follow-up
    7
    3
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eicosapentaenoic acid (EPA)
    Reporting group description
    EPA alone

    Reporting group title
    aspirin
    Reporting group description
    aspirin alone

    Reporting group title
    EPA + aspirin
    Reporting group description
    Combined EPA and aspirin

    Reporting group title
    placebo
    Reporting group description
    Double (capsule and tablet) placebo

    Reporting group values
    Eicosapentaenoic acid (EPA) aspirin EPA + aspirin placebo Total
    Number of subjects
    178 176 177 176 707
    Age categorical
    age categories by treatment arm
    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)
    90 92 76 90 348
        From 65-84 years
    88 84 101 86 359
        85 years and over
    0 0 0 0 0
    Age continuous
    age at enrolment
    Units: years
        arithmetic mean (standard deviation)
    65.2 ± 4.5 65.3 ± 4.5 65.6 ± 4.7 65.2 ± 4.6 -
    Gender categorical
    sex of trial subjects
    Units: Subjects
        Female
    40 36 31 37 144
        Male
    138 140 146 139 563

    End points

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    End points reporting groups
    Reporting group title
    Eicosapentaenoic acid (EPA)
    Reporting group description
    EPA alone

    Reporting group title
    aspirin
    Reporting group description
    aspirin alone

    Reporting group title
    EPA + aspirin
    Reporting group description
    Combined EPA and aspirin

    Reporting group title
    placebo
    Reporting group description
    Double (capsule and tablet) placebo

    Primary: Adenoma Detection Rate

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    End point title
    Adenoma Detection Rate
    End point description
    Adenoma Detection Rate = % number of individuals with one or more colorectal adenomas at surveillance colonoscopy at 12 months
    End point type
    Primary
    End point timeframe
    at 12 month surveillance colonoscopy
    End point values
    Eicosapentaenoic acid (EPA) aspirin EPA + aspirin placebo
    Number of subjects analysed
    153 [1]
    163 [2]
    161 [3]
    163 [4]
    Units: 1-100
    63
    61
    61
    61
    Notes
    [1] - participants with colorectal adenoma data at 12 months
    [2] - participants with colorectal adenoma data at 12 months
    [3] - participants with colorectal adenoma data at 12 months
    [4] - participants with colorectal adenoma data at 12 months
    Statistical analysis title
    EPA users vs no EPA users
    Statistical analysis description
    EPAanalysis by factorial margins
    Comparison groups
    Eicosapentaenoic acid (EPA) v aspirin v EPA + aspirin v placebo
    Number of subjects included in analysis
    640
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.81
    Method
    mixed-effects log-binomial regression
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.8
         upper limit
    6.9
    Statistical analysis title
    aspirin users vs no aspirin users
    Statistical analysis description
    aspirin analysis by factorial margins
    Comparison groups
    Eicosapentaenoic acid (EPA) v aspirin v EPA + aspirin v placebo
    Number of subjects included in analysis
    640
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.88
    Method
    mixed-effects log-binomial regression
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -8.5
         upper limit
    7.2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collected for all participants from first dose of trial treatment until the final trial visit (which coincides with the BSCP routine post-colonoscopy visit) scheduled for 2 weeks after the last dose of trial treatment.
    Adverse event reporting additional description
    Information about AEs, whether volunteered by the participant, discovered by SSP/RN/Investigator questioning or detected through physical examination, laboratory test or other investigation were collected and recorded on the CRF.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Eicosapentaenoic acid (EPA)
    Reporting group description
    EPA alone

    Reporting group title
    aspirin
    Reporting group description
    aspirin alone

    Reporting group title
    EPA + aspirin
    Reporting group description
    Combined EPA and aspirin

    Reporting group title
    placebo
    Reporting group description
    Double (capsule and tablet) placebo

    Serious adverse events
    Eicosapentaenoic acid (EPA) aspirin EPA + aspirin placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 177 (6.78%)
    12 / 174 (6.90%)
    5 / 170 (2.94%)
    13 / 176 (7.39%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    1 / 170 (0.59%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femoral artery occlusion
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood glucose increased
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder squamous cell carcinoma stage unspecified
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    2 / 176 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    1 / 170 (0.59%)
    0 / 176 (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
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    0 / 176 (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
    Prostate Cancer
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    1 / 170 (0.59%)
    0 / 176 (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
    Renal cancer
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 177 (0.56%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    5 / 177 (2.82%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    1 / 170 (0.59%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    0 / 176 (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
    Respiratory failure
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    1 / 170 (0.59%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    0 / 176 (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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    0 / 176 (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
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    0 / 176 (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
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    0 / 176 (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
    Colonic Abscess
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    1 / 176 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 177 (0.56%)
    0 / 174 (0.00%)
    0 / 170 (0.00%)
    0 / 176 (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
    Pharyngeal abscess
         subjects affected / exposed
    0 / 177 (0.00%)
    0 / 174 (0.00%)
    1 / 170 (0.59%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 177 (0.00%)
    1 / 174 (0.57%)
    0 / 170 (0.00%)
    0 / 176 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         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
    Eicosapentaenoic acid (EPA) aspirin EPA + aspirin placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    82 / 177 (46.33%)
    68 / 174 (39.08%)
    76 / 170 (44.71%)
    78 / 176 (44.32%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    38 / 177 (21.47%)
    20 / 174 (11.49%)
    11 / 170 (6.47%)
    16 / 176 (9.09%)
         occurrences all number
    38
    20
    11
    16
    UGI Symptoms
         subjects affected / exposed
    36 / 177 (20.34%)
    26 / 174 (14.94%)
    29 / 170 (17.06%)
    28 / 176 (15.91%)
         occurrences all number
    36
    26
    29
    28
    Lower Abdominal pain
         subjects affected / exposed
    37 / 177 (20.90%)
    10 / 174 (5.75%)
    9 / 170 (5.29%)
    21 / 176 (11.93%)
         occurrences all number
    37
    10
    9
    21
    Eructation
         subjects affected / exposed
    5 / 177 (2.82%)
    1 / 174 (0.57%)
    4 / 170 (2.35%)
    5 / 176 (2.84%)
         occurrences all number
    5
    1
    4
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Aug 2011
    SA02: seAFOod Trial Protocol, version 2.0, dated 08 August 2011. Changes to the protocol and PIL to ensure wording is clearer for study personnel and participants.
    30 Nov 2011
    SA04. seAFOod Trial Protocol, version 3.0, dated 28 November 2011. Inclusion criteria - age reduced to 73 to reflect BCSP surveillance guidelines. Exclusion criteria updated to exclude patients who are taking any non-aspirin anti-platelet therapy
    25 May 2012
    SA06:seAFOod trial Protocol, version 4.0, dated 04 May 2012. Change to exclusion criteria to now include patients who need a second repeat screening endoscopy, allowing inclusion of participants who have a second screening procedure.
    19 Jun 2013
    SA10: seAFOod trial Protocol, version 5.0, dated 17 June 2013. Change to inclusion criteria to include patients identified through the BowelScope FS screening programme
    14 Aug 2014
    SA14: seAFOod trial Protocol, version 6.0, dated 11 August 2014. Changes to the protocol in line with the introduction of the replacement capsule IMP. This includes additional information on the new EPA-TG formulation.

    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/30466866
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