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    Clinical Trial Results:
    A placebo controlled trial with Baclofen for the treatment of patients with clinical suspicion of rumination syndrome or esophageal belching

    Summary
    EudraCT number
    		 2011-002745-35
    Trial protocol
    		 BE  
    Global end of trial date
    30 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2021
    First version publication date
    06 Feb 2021
    Other versions
    Summary report(s)
    		 Article baclofen ruminatie

    Trial information

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    Trial identification
    Sponsor protocol code
    rum_baclofen2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03113396
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TARGID
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    TARGID, TARGID, 32 16344225, jan.tack@kuleuven.be
    Scientific contact
    TARGID, TARGID, 32 16344225, jan.tack@kuleuven.be
    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
    13 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The Primary objective of this study is to assess the efficacy (assessed by High resolution impedance-manometry recordings and questionnaires) of baclofen (lioresal®) 10mg three times daily vs. placebo in patients with clinical suspicion of rumination or supragastric belching.
    Protection of trial subjects
    Subjects identification is protected by using randomisation numbers.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2012
    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
    Belgium: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We included patients attending the outpatient clinic at the University Hospital Gasthuisberg (Leuven, Belgium) with a clinical suspicion of rumination syndrome and/or supra-gastric belching, according to Rome IV criteria

    Pre-assignment
    Screening details
    		 All patients underwent empirical treatment with proton pump inhibitors without full resolution of their symptoms. None of the patients underwent any form of behavioral therapy before inclusion in the study. Exclusion criteria were as follows: >75 years; a history of thoracic or upper abdominal surgery; and prior treatment with baclofen.

    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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Baclofen
    Arm description
    		 Medication consisted of identically looking capsules of baclofen (5 mg) or placebo. Patients were instructed to take one capsule t.i.d. during the fi rst week, which was increased to two capsules (10 mg baclofen) t.i.d. in the second week.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baclofen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Medication consisted of identically looking capsules of baclofen (5 mg) or placebo. Patients were instructed to take one capsule t.i.d. during the fi rst week, which was increased to two capsules (10 mg baclofen) t.i.d. in the second week.

    Arm title
    		 Placebo
    Arm description
    		 Medication consisted of identically looking capsules of baclofen (5 mg) or placebo. Patients were instructed to take one capsule t.i.d. during the fi rst week, which was increased to two capsules (10 mg baclofen) t.i.d. in the second week.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Medication consisted of identically looking capsules of baclofen (5 mg) or placebo. Patients were instructed to take one capsule t.i.d. during the fi rst week, which was increased to two capsules (10 mg baclofen) t.i.d. in the second week.

    Number of subjects in period 1
    		Baclofen Placebo
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 20 20
    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)
    		 20 20
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 42 (18 to 61) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 8 8

    End points

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    End points reporting groups
    Reporting group title
    Baclofen
    Reporting group description
    		 Medication consisted of identically looking capsules of baclofen (5 mg) or placebo. Patients were instructed to take one capsule t.i.d. during the fi rst week, which was increased to two capsules (10 mg baclofen) t.i.d. in the second week.

    Reporting group title
    Placebo
    Reporting group description
    		 Medication consisted of identically looking capsules of baclofen (5 mg) or placebo. Patients were instructed to take one capsule t.i.d. during the fi rst week, which was increased to two capsules (10 mg baclofen) t.i.d. in the second week.

    Primary: Number of flow events

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    End point title
    		 Number of flow events
    End point description
    End point type
    Primary
    End point timeframe
    From signing the informed consent until the end of the last measurement during the second study visit.
    End point values
    		 Baclofen Placebo
    Number of subjects analysed
    20
    20
    Units: Number
        median (inter-quartile range (Q1-Q3))
    15 (8 to 45)
    20 (13 to 86)
    Statistical analysis title
    		 Paired t test for flow events
    Comparison groups
    Placebo v Baclofen
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.02
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From signing the informed consent until the end of the last study visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Patients treated with baclofen
    Reporting group description
    		 -

    Serious adverse events
    		 Patients treated with baclofen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Patients treated with baclofen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 20 (35.00%)
    Nervous system disorders
    Sleepiness
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Acral paresthesia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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