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    Summary
    EudraCT Number:2022-000843-57
    Sponsor's Protocol Code Number:CRO22001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-08-26
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBulgarian Drug Agency
    A.2EudraCT number2022-000843-57
    A.3Full title of the trial
    A double-blind, randomized, cross-over, multi-center efficacy and safety study of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, randomized, cross-over, multi-center efficacy and safety study of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea
    A.3.2Name or abbreviated title of the trial where available
    Study of ibuprofen plus hyoscine butylbromide in patients with primary dysmenorrhoea
    A.4.1Sponsor's protocol code numberCRO22001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRONTIS HELLAS S.A.
    B.1.3.4CountryGreece
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRONTIS HELLAS S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRONTIS HELLAS S.A.
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address38 Sorou St.
    B.5.3.2Town/ cityMaroussi
    B.5.3.3Post codeGR15125
    B.5.3.4CountryGreece
    B.5.4Telephone number+302106109090
    B.5.5Fax number+30210108748
    B.5.6E-mailagni.grypioti@rontis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameibuprofen plus hyoscine butylbromide
    D.3.2Product code Test
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIbuprofen
    D.3.9.2Current sponsor codeTest
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHyoscine butylbromide
    D.3.9.1CAS number 149-64-4
    D.3.9.3Other descriptive nameHyoscine butylbromide
    D.3.9.4EV Substance CodeSUB14154MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Brufen 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMylan EPD bvba/sprl
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBrufen 400 mg
    D.3.2Product code Reference 1
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIbuprofen
    D.3.9.2Current sponsor codeReference 1
    D.3.9.4EV Substance CodeSUB08098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Buscopan 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Belgium
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBuscopan 10 mg
    D.3.2Product code Reference 2
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHyoscine butylbromide
    D.3.9.1CAS number 149-64-4
    D.3.9.3Other descriptive nameHyoscine butylbromide
    D.3.9.4EV Substance CodeSUB14154MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The efficacy and safety of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea will be investigated. Primary dysmenorrhea is the most common gynecological complaint in reproductive women. It is characterized by painful uterine contraction or menstrual cramps, occurring during menstruation without pelvic pathologies. Pain usually occurs intensely on the first or second day or the first 24–36 hours of menstruation.
    E.1.1.1Medical condition in easily understood language
    The efficacy and safety of ibuprofen plus hyoscine butylbromide for pain management due to primary dysmenorrhea will be investigated.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    To evaluate the tolerability of ibuprofen plus hyoscine butylbromide
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1]Female patients ≥18 and ≤40 years of age
    [2]Patients with a history of primary dysmenorrhea
    [3]Patients with moderate to severe pain in at least 5 of the last 6 menstrual cycles
    [4]Patients willing and able (e.g., mental and physical condition) to participate in all aspects of the study as evidenced by providing signed written informed consent
    E.4Principal exclusion criteria
    [1]History of hypersensitivity or intolerance to the active substances or any of the excipients of the study medication
    [2]History of hypersensitivity reactions (e.g., asthma, urticaria, angioedema or rhinitis) after taking other NSAIDs (e.g., acetylsalicylic acid or similar)
    [3]Any condition which might cause secondary dysmenorrhoea (e.g., endometriosis, salpingitis, adhesions)
    [4]Other likely causes of abdominal pain (e.g., gastric or peptic ulcer, inflammatory bowel disease, leiomyoma, pelvic inflammatory disease)
    [5]History of gastrointestinal bleeding
    [6]Conditions involving an increased tendency to bleeding
    [7]History of frequent dyspepsia, heartburn or indigestion
    [8]Severe heart failure (NYHA Class IV), hepatic failure and renal failure
    [9]Any of the following conditions:
    a)untreated narrow angle glaucoma,
    b)gastric outlet obstruction,
    c)intestinal atony,
    d)tachycardia,
    e)mechanical stenosis of the gastrointestinal tract, myasthenia gravis,
    f)megacolon
    [10]History of significant disease deemed by the investigator to render the patients unsuitable for inclusion
    [11]Concomitant major depression
    [12]Concomitant condition that may interfere with the absorption, distribution, metabolism, or excretion of the study medication
    [13]Previous (within 7 days before first study drug administration) intake or administration of analgesic, anti-inflammatory, antispasmodic or other therapy for dysmenorrhoea
    [14]Previous (within 7 days before first study drug administration) intake or administration of medications that might confound the assessment of pain relief, such as psychotropic drugs, antidepressants, sedative-hypnotics, NSAIDs, muscle relaxants*
    [15]Intake of oral contraceptives during the last 2 menstrual cycles preceding the trial
    [16]Administration of hormonal contraceptive devices during the last 2 menstrual cycles preceding the trial
    [17]Administration of long-acting depot contraceptives within the last 6 months preceding the trial
    [18]Patient is currently enrolled in, or has completed less than 30 days before the screening examination of the present trial another clinical trial with an investigational drug
    [19]Previous enrolment in this study
    [20]Pregnant or breast-feeding women
    [21]Women of childbearing potential unable or unwilling to undergo pregnancy tests and to practice adequate contraceptive measures. Reliable methods for women during the trial are:
    a)combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
    b)surgical intervention (e.g., tubal ligation),
    c)non-hormonal intrauterine device (IUD)
    d)sexual abstinence
    [22]Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study
    [23]Alcohol/drug dependence or abuse (excluding tobacco abuse)
    [24]Unreliability or lack of cooperation
    [25]Any other condition of the patient (e.g., serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the study treatment or may jeopardize patient’s safety, compliance or adherence to protocol requirements
    E.5 End points
    E.5.1Primary end point(s)
    Area under the curve from 0 to 4 hours after each of the first two doses (AUC0-4h) for the pain intensity differences (pre-dose - post dose)
    E.5.1.1Timepoint(s) of evaluation of this end point
    before intake as well as 10, 20, 30, 40, 50, 60 minutes and 1.5, 2, 3, 4 hours after each of the first 2 doses of study medication
    E.5.2Secondary end point(s)
    • Area under the curve from 0 to 2 hours after each of the first two doses for the pain intensity differences (pre-dose - post dose)
    • Area under the curve from 0 to 6 hours after each of the first two doses for the pain intensity differences (pre-dose - post dose)
    • Partial areas under the curve: 0 to 1 hour, 1 to 2 hours, and 2 to 6 hours after each of the first two doses for the pain intensity differences (pre-dose - post dose)
    • Pain intensity differences (pre-dose - post dose) at each of the pre-defined points in time: 10, 20, 30, 40, 50, 60 minutes and 1.5, 2, 3, 4, 5, and 6 hours after each of the first two doses of study medication
    • Percentage of patients who reach at least 30% reduction in pain intensity after each of the first two doses
    • Percentage of patients who reach at least 50% reduction in pain intensity after each of the first two doses
    • Time to at least 30% reduction in pain intensity after each of the first two doses
    • Time to at least 50% reduction in pain intensity after each of the first two doses
    • Number of patients using rescue medication within the first 2 hours post dose
    • Number of patients using rescue medication within the entire duration of treatment
    • Patient’s global ratings of pain relief
    E.5.2.1Timepoint(s) of evaluation of this end point
    • from 0 to 2 hours after each of the first two doses
    • from 0 to 6 hours after each of the first two doses
    • 0 to 1 hour, 1 to 2 hours, and 2 to 6 hours after each of the first two doses
    • 10, 20, 30, 40, 50, 60 minutes and 1.5, 2, 3, 4, 5, and 6 hours after each of the first two doses of study medication
    • after each of the first two doses
    • within the first 2 hours post dose
    • entire duration of treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The last visit and end of the trial is the final examination, performed up to 7 days after day 1 in last cycle.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 54
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-06-28
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