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    Clinical Trial Results:
    Misoprostol for the Healing of Small Bowel Ulceration in Patients with Obscure Blood Loss while Taking Low-Dose Aspirin or Non-Steroidal Anti-inflammatory Drugs [MASTERS Trial]

    Summary
    EudraCT number
    2013-003187-31
    Trial protocol
    GB  
    Global end of trial date
    11 Oct 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    11 Sep 2020
    First version publication date
    11 Sep 2020
    Other versions
    Summary report(s)
    Friendly Summary - MASTERS Trial

    Trial information

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    Trial identification
    Sponsor protocol code
    GN09CA403
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02202967
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    NHS Ayrshire & Arran
    Sponsor organisation address
    Simpson Street, Kilmarnock, United Kingdom, KA2 0BE
    Public contact
    Dr A S Taha, NHS Ayrshire & Arran, University Hospital Crosshouse, 44 1563827280, ali.taha1@btinternet.com
    Scientific contact
    Dr A S Taha, NHS Ayrshire & Arran, University Hospital Crosshouse, 44 1563827280, ali.taha1@btinternet.com
    Sponsor organisation name
    NHS Greater Glasgow & Clyde R&D Office, Dykebar Hospital
    Sponsor organisation address
    Grahamston Road, Paisley, United Kingdom, PA2 7DE
    Public contact
    Dr Maureen Travers, NHS Greater Glasgow & Clyde, 44 141 314 4012, Maureen.Travers@ggc.scot.nhs.uk
    Scientific contact
    Dr Maureen Travers, NHS Greater Glasgow & Clyde, 44 141 314 4012, Maureen.Travers@ggc.scot.nhs.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 Nov 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In cases of iron deficiency anaemia or obscure gastrointestinal bleeding: To assess the efficacy of an off-patent prostaglandin analogue, misoprostol, in healing of small bowel mucosal damage while continuing to take low-dose aspirin and/ or NSAIDs.
    Protection of trial subjects
    Exclusion of women of child-bearing potential if not using reliable contraceptive methods.
    Background therapy
    N/A
    Evidence for comparator
    Misoprostol is licensed for the healing of peptic ulcers caused by aspirin or non-steroidal anti-inflammatory drugs. Its effect on smal bowel ulcers is not known in users of these drugs.
    Actual start date of recruitment
    07 Jan 2016
    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: 104
    Worldwide total number of subjects
    104
    EEA total number of subjects
    104
    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)
    80
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment dates: 7 January 2016 - 11 October 2017.

    Pre-assignment
    Screening details
    We recruited patients (aged ≥18 years) with small bowel ulcers and taking aspirin, NSAIDs, or both for a minimum of 4 weeks. Eligible patients had evidence of obscure gastrointestinal bleeding (iron deficiency anaemia, a decrease in haemoglobin level of ≥20 × 10³ mg/L, or positive faecal occult blood test) and normal upper endoscopy and colonoscopy

    Pre-assignment period milestones
    Number of subjects started
    104
    Number of subjects completed
    104

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Randomisation was carried out using an interactive voice response system that allocated therapy packs per patient by telephone. The randomisation schedule was computer-generated, using the method of randomised permuted blocks of length 6 without stratification. Patients, investigators, and assessors were masked to study treatment. Misoprostol and placebo capsules were identical in shape, colour, odour, and taste.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Active treatment
    Arm description
    patients taking misoprostol
    Arm type
    Active comparator

    Investigational medicinal product name
    Misoprostol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 ug four times daily

    Arm title
    Placebo group
    Arm description
    Placebo
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    Active treatment Placebo group
    Started
    52
    52
    Completed
    52
    52

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active treatment
    Reporting group description
    patients taking misoprostol

    Reporting group title
    Placebo group
    Reporting group description
    Placebo

    Reporting group values
    Active treatment Placebo group Total
    Number of subjects
    52 52 104
    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
        median (inter-quartile range (Q1-Q3))
    68 (58 to 71) 63 (57 to 71) -
    Gender categorical
    Units: Subjects
        Female
    22 28 50
        Male
    30 24 54

    End points

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    End points reporting groups
    Reporting group title
    Active treatment
    Reporting group description
    patients taking misoprostol

    Reporting group title
    Placebo group
    Reporting group description
    Placebo

    Primary: Numbers of patients with fully healed ulcers and erosions at end of the trial

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    End point title
    Numbers of patients with fully healed ulcers and erosions at end of the trial
    End point description
    End point type
    Primary
    End point timeframe
    The end of the study at 8 weeks
    End point values
    Active treatment Placebo group
    Number of subjects analysed
    50 [1]
    52 [2]
    Units: numbers of patients
    27
    9
    Attachments
    Outcomes of MASTERS Trial
    Notes
    [1] - Two completed patients were excluded from the final analysis because of protocol violation
    [2] - correct number
    Statistical analysis title
    Fisher's exact test
    Comparison groups
    Active treatment v Placebo group
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0002
    Method
    Fisher exact
    Parameter type
    negative binomial regression models
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    19.5
         upper limit
    53.9

    Secondary: Change in haemoglobin level

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    End point title
    Change in haemoglobin level
    End point description
    End point type
    Secondary
    End point timeframe
    8 weeks
    End point values
    Active treatment Placebo group
    Number of subjects analysed
    50
    52
    Units: mg/mL
        median (inter-quartile range (Q1-Q3))
    136 (121 to 145)
    136 (121 to 145)
    Statistical analysis title
    Multivariable regression analysis
    Comparison groups
    Active treatment v Placebo group
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.82
    Method
    multivariable regression
    Parameter type
    Median difference (final values)
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.84
         upper limit
    4.24

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    End of trial at 8 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Active treatment
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Active treatment Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (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: 1%
    Non-serious adverse events
    Active treatment Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 50 (46.00%)
    22 / 52 (42.31%)
    Gastrointestinal disorders
    Pain
    Additional description: Abdominal pain was reported in 21.5% of the misoprostol group vs 24.6% of the placebo group
         subjects affected / exposed
    10 / 50 (20.00%)
    13 / 52 (25.00%)
         occurrences all number
    10
    13
    Diarrhoea
    Additional description: Diarrhoea was reported by 20% of the misoprostol group vs. 14% of the placebo group
         subjects affected / exposed
    11 / 50 (22.00%)
    6 / 52 (11.54%)
         occurrences all number
    11
    6
    Vomiting
    Additional description: Nausea/ vomiting were reported by 20% of the misoprostol group vs 19.3% of the placebo group
         subjects affected / exposed
    9 / 50 (18.00%)
    7 / 52 (13.46%)
         occurrences all number
    9
    7

    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.
    N/A

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/29754836
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