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    Clinical Trial Results:
    A double-blind, randomized, cross-over, multi-center efficacy and safety study of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea

    Summary
    EudraCT number
    		 2022-000843-57
    Trial protocol
    		 BG  
    Global end of trial date
    09 Apr 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Feb 2025
    First version publication date
    19 Feb 2025
    Other versions
    Summary report(s)
    		 Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    CRO22001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    RONTIS HELLAS S.A.
    Sponsor organisation address
    38 Sorou St., Maroussi, Greece, GR15125
    Public contact
    Project Manager, RONTIS HELLAS S.A., +30 2106109090, agni.grypioti@rontis.com
    Scientific contact
    Project Manager, RONTIS HELLAS S.A., +30 2106109090, agni.grypioti@rontis.com
    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
    09 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of a combination of ibuprofen plus hyoscine butylbromide as compared to ibuprofen alone and hyoscine butylbromide alone for the management of pain due to primary dysmenorrhea.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles of Good Clinical Practice, according to the ICH Harmonized Tripartite Guideline and the local laws and regulations of the countries of clinical sites.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jan 2023
    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
    Bulgaria: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    54
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population consisted of female patients, 18 to 40 years old with a history of primary dysmenorrhoea and moderate to severe pain in at least 5 of the last 6 mentrual cycles.

    Pre-assignment
    Screening details
    		 The Screening Period lasted up to 30 days before start of treatment. A total of 57 subjects were screened. A total of 55 subjects were randomized and 54 of them were treated with study medication (full analysis set). 53 patients completed the trial.

    Period 1
    Period 1 title
    Treatment (overall trial) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Test
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ibuprofen plus hyoscine butylbromide
    Investigational medicinal product code
    Test IMP (T)
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one hard capsule three times per day (=1200 mg ibuprofen and 60 mg hyoscine butylbromide)

    Arm title
    		 REFERENCE 1
    Arm description
    		 Brufen 400 mg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Brufen 400 mg
    Investigational medicinal product code
    Reference 1 IMP (R1)
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one hard capsule three times per day (=1200 mg ibuprofen)

    Arm title
    		 REFERENCE 2
    Arm description
    		 Buscopan 10 mg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Buscopan 10 mg
    Investigational medicinal product code
    Reference 2 IMP (R2)
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one hard capsule three times per day (= 60 mg hyoscine butylbromide)

    Number of subjects in period 1
    		Test REFERENCE 1 REFERENCE 2
    Started
    54
    53
    53
    Completed
    53
    53
    53
    Not completed
    1
    0
    0
         randomzed by mistake
    1
    -
    -

    Baseline characteristics

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

    Reporting group values
    		 Treatment (overall trial) Total
    Number of subjects
    		 54 54
    Age categorical
    Units: Subjects
        below 18 years
    		 0 0
        18-30 years
    		 29 29
        31-40 years
    		 24 24
        over 40 years
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29.1 ( 7.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 54 54
        Male
    		 0 0
    Race
    Units: Subjects
        Whie
    		 54 54
        American Indian or Alaska Native
    		 0 0
        Black or African American
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Multiple
    		 0 0
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 165.8 ( 4.88 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 62.4 ( 15.5 ) -
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 22.6 ( 5.06 ) -

    End points

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

    Reporting group title
    REFERENCE 1
    Reporting group description
    		 Brufen 400 mg

    Reporting group title
    REFERENCE 2
    Reporting group description
    		 Buscopan 10 mg

    Subject analysis set title
    per protocol
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Treatment (overall period)

    Primary: AUC(0-4h)

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    End point title
    		 AUC(0-4h) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Treatment (overall period)
    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: The synopsis of the study report was attached.
    End point values
    		 per protocol
    Number of subjects analysed
    54
    Units: ng*h/ml
    geometric mean (standard deviation)
        T vs R1
    0.28 ( 0.6354 )
        T vs R2
    0.47 ( 0.8025 )
    No statistical analyses for this end point

    Secondary: AUC(0-2h)

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    End point title
    		 AUC(0-2h)
    End point description
    End point type
    Secondary
    End point timeframe
    Treatment (overall period)
    End point values
    		 per protocol
    Number of subjects analysed
    54
    Units: ng*h/ml
    geometric mean (standard deviation)
        T vs R1
    0.59 ( 1.2072 )
        T vs R2
    0.90 ( 1.1897 )
    No statistical analyses for this end point

    Secondary: AUC(0-6h)

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    End point title
    		 AUC(0-6h)
    End point description
    End point type
    Secondary
    End point timeframe
    Treatment (overall period)
    End point values
    		 per protocol
    Number of subjects analysed
    54
    Units: ng*h/ml
    geometric mean (standard deviation)
        T vs R1
    -0.05 ( 0.3250 )
        T vs R2
    0.21 ( 0.4083 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Collection of adverse events started after signing informed consent during the Pre-assignment period (non treatment emergent AEs) and during the treatment period of the trial (TEAEs).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Test
    Reporting group description
    		 ibuprofen plus hyoscine butylbromide

    Reporting group title
    Reference 1
    Reporting group description
    		 Brufen 400 mg

    Reporting group title
    Reference 2
    Reporting group description
    		 Buscopan 10 mg

    Serious adverse events
    		 Test Reference 1 Reference 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 54 (0.00%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Test Reference 1 Reference 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 54 (1.85%)
    0 / 53 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    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
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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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