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    Summary
    EudraCT Number:2017-000244-18
    Sponsor's Protocol Code Number:BAY1128688/17472
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-000244-18
    A.3Full title of the trial
    A randomized, placebo-controlled, double-blind, parallel-group, multi-center, exploratory dose-response study to assess the efficacy and safety of different oral doses of BAY 1128688 in women with symptomatic endometriosis over a 12-week treatment period
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test whether study drug BAY1128688 brings pain relief to women with endometriosis and if so to get a first idea which dose(s) work best.
    A.3.2Name or abbreviated title of the trial where available
    Akrendo 1
    A.4.1Sponsor's protocol code numberBAY1128688/17472
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointClinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.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 nameBAY 1128688 coated tablet 3 mg
    D.3.2Product code BAY 1128688 coated tablet 3 mg 001
    D.3.4Pharmaceutical form Coated tablet
    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 INNnot available
    D.3.9.1CAS number 1428988-21-9
    D.3.9.2Current sponsor codeBAY 1128688
    D.3.9.3Other descriptive nameBAY 1128688
    D.3.9.4EV Substance CodeSUB130437
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 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 nameBAY1128688 coated tablet 10 mg
    D.3.2Product code BAY1128688 coated tablet 10 mg 110
    D.3.4Pharmaceutical form Coated tablet
    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 INNnot available
    D.3.9.1CAS number 1428988-21-9
    D.3.9.2Current sponsor codeBAY 1138688
    D.3.9.3Other descriptive nameBAY 1128688
    D.3.9.4EV Substance CodeSUB130437
    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.IMP: 3
    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 nameBAY 1128688 coated tablet 30 mg
    D.3.2Product code BAY 1128688 coated tablet 30 mg 302
    D.3.4Pharmaceutical form Coated tablet
    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 INNnot available
    D.3.9.1CAS number 1428988-21-9
    D.3.9.2Current sponsor codeBAY 1128688
    D.3.9.3Other descriptive nameBAY 1128688
    D.3.9.4EV Substance CodeSUB130437
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 4
    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 nameBAY1128688 coated tablet 60 mg
    D.3.2Product code BAY1128688 coated tablet 60 mg 602
    D.3.4Pharmaceutical form Coated tablet
    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 INNnot available
    D.3.9.1CAS number 1428988-21-9
    D.3.9.2Current sponsor codeBAY 1128688
    D.3.9.3Other descriptive nameBAY 1128688
    D.3.9.4EV Substance CodeSUB130437
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Endometriosis
    E.1.1.1Medical condition in easily understood language
    Endometriosis is a disease of young women (before menopause); women suffer from pain in the pelvic/ lower abdominal area and difficulties to become pregnant
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014788
    E.1.2Term Endometriosis related pain
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014778
    E.1.2Term Endometriosis
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Explore the dose response relationship of different doses of BAY 1128688 compared to placebo in the treatment of endometriosis-related symptoms over a 12-week treatment period
    E.2.2Secondary objectives of the trial
    Assessment of safety and tolerability of BAY 1128688 over a 12-week treatment period
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women of at least 18 years of age at the time of signing of informed consent
    - Women with endometriosis confirmed by at least one of the two criteria:
    . Visually-confirmed endometriosis within 10 years
    . Imaging-confirmed endometriosis within 12 months prior to screening
    - Both criteria regarding pain symptoms have to be fulfilled:
    . At Visit 1: at least a score of 40 (for subjects not on hormonal treatment) on visual analogue scale (VAS; 4-week recall period) for endometriosis-associated pelvic pain (EAPP), and at least a score of 30 for subjects on hormonal treatment. Subjects are regarded to be on hormonal treatment if hormonal contraception was used any time during the 4 weeks prior to Visit 1.
    . During the screening period (before randomization):
    o At least 24 daily diary entries during the 28 consecutive days starting on the first day with menstrual bleeding on or after Visit 1
    o A sum of at least 98 of the available entries in the endometriosis symptom
    diary (ESD) item 1 (‘worst pain’ on the daily numerical rating scale [NRS]; 24-hour recall), corresponding to an average score of ≥ 3.5 over the 28-day period
    - Willingness to use only ibuprofen as rescue pain medication for EAPP, if required, according to investigator’s instruction
    - Good general health (except for findings related to endometriosis) as proven by medical
    history, physical and gynecological examinations and laboratory test results
    - Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the
    previous 6 months). Human papilloma virus (HPV) testing in subjects with atypical squamous cells of unknown significance (ASCUS) can be used as an adjunctive test.
    Subjects with ASCUS can be included if they are negative for high-risk HPV strains.
    - Willingness to use non-hormonal barrier method for contraception (here spermicide-coated
    condoms) from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner or use of copper intrauterine device (IUD) or commitment to abstinence and refrain from using hormonal contraception.
    9. Willingness to be trained/instructed in using barrier method of contraception (here
    spermicide-coated condoms)
    10. Willingness and ability to attend the scheduled study visits and comply with study
    procedures
    E.4Principal exclusion criteria
    - Pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) OR wish for pregnancy during the study
    - Hypersensitivity to any ingredient of the study drug and/or ibuprofen
    - Contraindications to study drug (as described in the investigator brochure) and/or ibuprofen (based on the country-specific label)
    - Presence of at least one of the following risks related to bilirubin metabolism and liver function at Visit 1:
     . Total bilirubin above upper limit of normal (ULN)
     . Glutamic oxaloacetic transaminase (GOT) / aspartate aminotransferase (AST) above ULN
     . Glutamic pyruvic transaminase (GPT) / alanine aminotransferase (ALT) above ULN
     . Alkaline phosphatase (AP) equal or above 2 times ULN
     . Positive results for a) hepatitis B virus surface antigen (HBsAg) or b) hepatitis C virus antibodies and mRNA (anti-HCV and HCV-mRNA)
    . Any disease influencing bilirubin values such as thalassemia, Morbus Gilbert/Meulengracht, Crigler-Najjar syndrome, Rotor syndrome or other
    genetic predispositions to altered bilirubin metabolism
    - Presence of at least one of the following risks related to hyperandrogenemia at Visit 1
     . Total testosterone above 1.5 times ULN
     . Any disease influencing testosterone metabolism such as adrenogenital syndrome Diagnosed polycystic ovary syndrome (PCOS) based on
    Rotterdam criteria or suspicion of polycystic ovaries (elements of the Rotterdam criteria but insufficient for diagnosis e.g. clinical features of PCOS
    like hirsutism or biochemical features of PCOS like hyperandrogenemia or oligo-/amenorrhea or polycystic ovary)
    - Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug, for example impaired function of kidneys and liver, chronic bowel disease
    - Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results (e.g. pain caused by other diseases such as uterine fibroids, fibromyalgia, chronic bowel disease)
    - Any disease or condition that may worsen under treatment according to the assessment and opinion of the investigator
    - Abnormal vaginal/genital bleeding in terms of regularity or heaviness (caused by organic reasons such as uterine fibroids or uterine polyps or undiagnosed; adenomyosis-related changes in regularity or heaviness of vaginal/genital bleeding are not an exclusion criterion)
    - Suspicion of menopausal transition, such as absence of regular menstrual cycles based on investigator’s judgment (absence of information regarding menstrual bleeding pattern e.g. due to long term use of hormonal contraception and elevated FSH plasma concentrations
    at screening are not an exclusion criterion)
    - Uncontrolled thyroid disorders (well controlled hyper- and hypothyroid disorders, as proven by thyroid-stimulating hormone [TSH] at screening are allowed)
    - Any medication that could result in excessive accumulation, increased or impaired metabolism, or altered excretion of the study drug or might interfere with the conduct of the study or the interpretation of the results such as:
     . Moderate or strong CYP3A4 enzyme and P-gp inducers (with an expected decrease in systemic exposure to 50% or less) (see Appendix 16.1)
     . Moderate or strong CYP3A4 enzyme and P-gp inhibitors (with an expected increase in systemic exposure of greater than 2-fold) (see Appendix 16.2)
    These medications should be stopped at Visit 1 and are prohibited throughout the study.
    - Any drug treatments which interfere with the conduct of the study or the interpretation of the results
    - Any findings that require further diagnostic procedures to avoid harm to the subject (e.g. ovarian tumors of uncertain origin or pelvic masses of unclear etiology)
    - History of hysterectomy, tubal-ligation or bilateral ovariectomy
    - Abuse of alcohol, drugs, or medicine (e.g. laxatives)
    - Major surgery scheduled for the study period
    - Non-responsiveness of EAPP to GnRH-a or an endometriosis related surgery (partial response is not exclusionary). Non-responsiveness refers to clinical judgment of the investigator i.e. no cross-site definition of threshold provided.
    - Previous (within the last 3 months before screening visit) or concomitant participation in another clinical study with an investigational medicinal product(s)
    - Previous assignment to treatment during this study
    - Inability to comply with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site
    - Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g. employee or student of the investigational site) or sponsor’s staff
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in mean pain of the 7 days with worst EAPP from baseline (last 28 days before SoT visit) to end of treatment (last 28 days of the treatment period, Day 57 - 84) (measured on the NRS by item 1 of the ESD).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    The secondary safety variable is the incidence of treatment-emergent adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 weeks
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Effects of BAY 1128688 on health-related quality of life
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA91
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days5
    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: 120
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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 Decision2017-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-22
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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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