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    Clinical Trial Results:
    Efficacy of Endothelin 1 receptor antagonist Bosentan in secondary Raynauds Syndrom

    Summary
    EudraCT number
    		 2004-002686-21
    Trial protocol
    		 AT  
    Global end of trial date
    29 Dec 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Mar 2022
    First version publication date
    01 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Bosentan1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University
    Sponsor organisation address
    Anichstrasse 35, Innsbruck, Austria, 6020
    Public contact
    Wolfram Jaschke Consultant, Department of Dermatology, Venereology and Allergy Medical University Innsbruck, +43 51250483671, wolfram.jaschke@i-med.ac.at
    Scientific contact
    Wolfram Jaschke Consultant, Department of Dermatology, Venereology and Allergy Medical University Innsbruck, +43 51250483671, wolfram.jaschke@i-med.ac.at
    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
    29 Dec 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy of bosentan in secondary raynauds syndrome.
    Protection of trial subjects
    Patients were excluded if they had primary RP (Raynaud’s phenomenon) or RP not associated with SSc (systemic sclerosis), active digital ulcer or gangrene, abnormal haemostasis, platelet alterations and evidence of uncontrolled cardiovascular, pulmonary, hepatic or renal disease. Other exclusion criteria were treatment with prostanoids within 3 months of enrolment, previous use of bosentan or other ET receptor blockers, phosphodiesterase-V-inhibitors and any medication contraindicating the administration of bosentan. Vasodilator drugs for arterial hypertension and the use of hand warmers or electric gloves were allowed, whereas topical treatment with glyceryl nitrate and therapy with paraffin wax hand baths were discontinued 4 weeks before starting the study. Women of child-bearing potential were required to have a negative pregnancy test before study initiation and apply effective contraceptive methods. All subjects were informed about the nature and aim of the study, and gave their informed written consent to participate.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Feb 2005
    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
    Austria: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    14
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was designed as a prospective, randomized, single-centre, observer-blinded, placebo-controlled trial and was conducted over the cold winter months to maximize the development of RP (Raynaud’s phenomenon) as well as to minimize the seasonal effects on RP.

    Period 1
    Period 1 title
    Pre-treatment (2 weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Selection
    Arm description
    		 Randomization of trial participants
    Arm type
    		 Selection

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Selection
    Started
    17
    Completed
    17
    Period 2
    Period 2 title
    Treatment (16 weeks)
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bosentan
    Arm description
    		 62.5mg bosentan twice daily for 4 weeks, followed by 125mg twice daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bosentan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    62.5mg bosentan twice daily for 4 weeks, followed by 125mg twice daily for 12 weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    62.5mg placebo twice daily for 4 weeks, followed by 125mg twice daily for 12 weeks

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: In the pre-treatment period subjects were randomized to one of the arms.
    Number of subjects in period 2
    		Bosentan Placebo
    Started
    9
    8
    Completed
    8
    8
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -
    Period 3
    Period 3 title
    Post-treatment follow-up (8 weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Follow-up
    Arm description
    		 Follow-up visits were conducted for the trial participants.
    Arm type
    		 Follow-up

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3
    		Follow-up
    Started
    16
    Completed
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bosentan
    Reporting group description
    		 62.5mg bosentan twice daily for 4 weeks, followed by 125mg twice daily for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Bosentan Placebo Total
    Number of subjects
    		 9 8 17
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 9 8 17
        From 65-84 years
    		 0 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 43 ( 11.2 ) 63.5 ( 9.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 8 17
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Selection
    Reporting group description
    		 Randomization of trial participants
    Reporting group title
    Bosentan
    Reporting group description
    		 62.5mg bosentan twice daily for 4 weeks, followed by 125mg twice daily for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo
    Reporting group title
    Follow-up
    Reporting group description
    		 Follow-up visits were conducted for the trial participants.

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint [1]
    End point description
    The primary outcome was the change in severity of RP attacks, measured by the Raynaud condition score (RCS), and its related variables frequency, duration and pain at the end of the treatment period at Week 16 compared with the baseline.
    End point type
    Primary
    End point timeframe
    Day 1 to Week 16
    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: Statistical analysis was done within groups.
    End point values
    		 Bosentan Placebo
    Number of subjects analysed
    8
    8
    Units: RCS Score
        median (confidence interval 95%)
    -36 (-75 to 4)
    -31 (-66 to 4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 to week 16
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Bosentan
    Reporting group description
    		 62.5mg bosentan twice daily for 4 weeks, followed by 125mg twice daily for 12 weeks

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Bosentan Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 8 (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: 5%
    Non-serious adverse events
    		 Bosentan Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    Skin and subcutaneous tissue disorders
    treatment-related peripheral oedema
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 8 (0.00%)
         occurrences all number
    1
    0

    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/20040526
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