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    Clinical Trial Results:
    Prospective, randomised, placebo controlled, double blind monocenter trial for the prophylactic treatment of diarrhoea with rifaximin for travellers to South- and Southeast-Asia

    Summary
    EudraCT number
    		 2007-003986-42
    Trial protocol
    		 DE  
    Global end of trial date
    21 Sep 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Sep 2022
    First version publication date
    03 Sep 2022
    Other versions
    Summary report(s)
    		 Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    Rifa1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00979056
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Tübingen
    Sponsor organisation address
    Geissweg 3, Tübingen, Germany,
    Public contact
    Dr. Diane Egger-Adam, Universitätsklinikum Tübingen, Institute of Tropical Medicine, Travel Medicine & Human Parasitology, diane.egger-adam@uni-tuebingen.de
    Scientific contact
    Dr. Diane Egger-Adam, Universitätsklinikum Tübingen, Institute of Tropical Medicine, Travel Medicine & Human Parasitology, diane.egger-adam@uni-tuebingen.de
    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 Apr 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of the prophylactic treatment with rifaximin to prevent travellers diarrhoea
    Protection of trial subjects
    Study subject were trained on how to send-treat a travellers diarrhoea, if occurring. e
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2009
    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
    Germany: 258
    Worldwide total number of subjects
    258
    EEA total number of subjects
    258
    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)
    258
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Individuals consulting the University of Tübingen travel clinic for pre-travel advice, who planned to travel to one or more countries in south or southeast Asia for 6–28 days, and who had a predictably high risk of travellers’ diarrhoea at the time of recruitment,1 were invited to participate

    Pre-assignment
    Screening details
    		 6139 subjects were screened, 1198 received the trial information and 258 were enrolled.

    Period 1
    Period 1 title
    Recruitment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rifaximin
    Investigational medicinal product code
    Other name
    Xifaxan, Normix, ATC code A07AA11, Chemical Abstracts Service (CAS) 80621814
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg every 12-18h (400 mg per day)

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placeo
    Investigational medicinal product code
    Other name
    placebo tablets (Catalent Pharma Solutions, Schorndorf, Germany)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet every 12-18h (2 tables per day)

    Number of subjects in period 1
    		Verum Placebo
    Started
    129
    129
    Completed
    129
    129
    Period 2
    Period 2 title
    Analysis Set
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Verum
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rifaximin
    Investigational medicinal product code
    Other name
    Xifaxan, Normix, ATC code A07AA11, Chemical Abstracts Service (CAS) 80621814
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg every 12-18h (400 mg per day)

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placeo
    Investigational medicinal product code
    Other name
    placebo tablets (Catalent Pharma Solutions, Schorndorf, Germany)
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 tablet every 12-18h (2 tables per day)

    Number of subjects in period 2
    		Verum Placebo
    Started
    129
    129
    Completed
    122
    117
    Not completed
    7
    12
         Lost to follow-up
    7
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Verum Placebo Total
    Number of subjects
    		 129 129 258
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 129 129 258
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 29 (24 to 37) 28 (26 to 36) -
    Gender categorical
    Units: Subjects
        Female
    		 66 65 131
        Male
    		 63 64 127
    Days of travel
    Units: day
        median (full range (min-max))
    		 22 (16 to 26) 21 (17 to 26) -

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: primary endpoint

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    End point title
    		 primary endpoint
    End point description
    Efficacy of the prevention of travellers diarrhea with rifaximin by measurement of frequency and consistence of the stool. Diarrhea will be defined as passage of >2 unformed stools/24 hr plus one or more signs or symptoms of enteric infection.
    End point type
    Primary
    End point timeframe
    From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
    End point values
    		 Verum Placebo
    Number of subjects analysed
    122
    117
    Units: units
    30
    48
    Statistical analysis title
    		 Analysis
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    239
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.5
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Secondary: 1. Secondary endpoint

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    End point title
    		 1. Secondary endpoint
    End point description
    Documentation of adverse effects and tolerance of prophylaxis with rifaximin.
    End point type
    Secondary
    End point timeframe
    From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
    End point values
    		 Verum Placebo
    Number of subjects analysed
    122
    117
    Units: incidences
    112
    112
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first day of the travel (travel period between 6 and 28 days) to 1 week after the subject's return to Germany
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Verum Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 117 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    right lower quadrant abdominal pain
    Additional description: Grad 3 right lower quadrant abdominal pain 72h after serum intake
         subjects affected / exposed
    1 / 122 (0.82%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Verum Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    112 / 122 (91.80%)
    112 / 117 (95.73%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    53 / 122 (43.44%)
    45 / 117 (38.46%)
         occurrences all number
    96
    83
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    66 / 122 (54.10%)
    77 / 117 (65.81%)
         occurrences all number
    136
    152
    Flatulence
         subjects affected / exposed
    57 / 122 (46.72%)
    55 / 117 (47.01%)
         occurrences all number
    121
    100
    Nausea
         subjects affected / exposed
    42 / 122 (34.43%)
    57 / 117 (48.72%)
         occurrences all number
    62
    85
    Vomiting
         subjects affected / exposed
    19 / 122 (15.57%)
    19 / 117 (16.24%)
         occurrences all number
    20
    23
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    26 / 122 (21.31%)
    12 / 117 (10.26%)
         occurrences all number
    38
    17
    Metabolism and nutrition disorders
    Fever
    Additional description: Fever more or equal to 37.8°C
         subjects affected / exposed
    18 / 122 (14.75%)
    23 / 117 (19.66%)
         occurrences all number
    24
    34

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24012319
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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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