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    Summary
    EudraCT Number:2008-005104-10
    Sponsor's Protocol Code Number:ADX10059-204
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-23
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2008-005104-10
    A.3Full title of the trial
    A phase 2B, randomised, double-blind, placebo-controlled, parallel group,
    multi-centre study to investigate the efficacy, mechanism of action,
    pharmacokinetics, safety and tolerability of the mGluR5 negative
    allosteric modulator ADX10059 as monotherapy in patients with
    Gastroesophageal Reflux Disease (GERD)
    A.4.1Sponsor's protocol code numberADX10059-204
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAddex Pharma SA
    B.1.3.4CountrySwitzerland
    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 organisation
    B.5.2Functional name of contact point
    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 nameADX10059
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 assigned yet
    D.3.9.1CAS number 757950-09-7
    D.3.9.2Current sponsor codeADX10059
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60 to mg
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCapsule*
    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
    Gastroesophageal Reflux Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018203
    E.1.2Term GERD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy on GERD symptoms (heartburn and/or regurgitation)
    of ADX10059 as a monotherapy compared with placebo when taken twice
    daily for 15 days, by patients with GERD.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of ADX10059 compared with placebo on: heartburn,
    regurgitation, sleep disturbance due to GERD, occurrence of nocturnal and
    post-prandial GERD, patient and investigator global assessment of study
    medication, requirement for rescue medication, Patient Assessment of Upper
    Gastrointestinal Disorders Symptoms Questionnaire (PAGI-SYM) and
    Hospital Anxiety and Depression Score (HADS)
    • To evaluate the safety and tolerability after repeated administration of
    ADX10059
    • In a subset of patients, to evaluate the mechanism of action and
    pharmacokinetics (PK) of ADX10059 in GERD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be invited to participate if he/she meets the following inclusion criteria:
    1. is willing and able to provide written informed consent
    2. is male or female and aged 18 to 70 years, inclusive
    3. is diagnosed with typical GERD and is well controlled on a standard clinical
    symptom control dose of PPI treatment, defined as symptom free on >= 5 out of
    7 days and presenting with =< 2 days of mild heartburn and/or regurgitation per
    week whilst on treatment, and is prepared to stop their standard dose of PPI
    treatment from Screening to the end of the 15 day treatment period
    4. has mild symptoms of heartburn and/or regurgitation on >= 4 out of 7 days or
    moderate/severe symptoms on >= 2 out of 7 days off their PPI treatment, as
    confirmed from the eDiary data recorded on Days -8 to -2 inclusive
    5. has a body mass index (BMI) of =< 32 kg/m2
    6. has an ability to communicate well with the study staff and to comply with the
    requirements of the entire study including compliance with eDiary completion
    E.4Principal exclusion criteria
    A patient will be excluded from study participation if he/she meets any of the
    following criteria:
    1. has exclusively atypical symptoms of GERD, such as coughing, sore throat, respiratory symptoms etc. (i.e. atypical symptoms in the absence of heartburn and / or regurgitation)
    2. has symptoms that have been shown not to be associated with GERD, acid or
    non-acid
    3. has a history of erosive oesophagitis as demonstrated by endoscopy within the
    previous 12 months of Grade B or worse (Los Angeles classification grading
    score)
    4. has a documented history of hiatus hernia > 3 cm
    5. has a current diagnosis of co-existing psychiatric disease that, according to the investigator, could interfere with the conduct of the study
    6. has a known clinically significant allergy or known hypersensitivity to drugs that,
    in the opinion of the investigator, may affect the patient’s safety
    7. has clinically significant abnormal laboratory parameters at Screening, in particular, liver or renal functions tests greater than twice the upper limit of normal (ULN) or any other clinically significant biochemical or haematological abnormality as determined by the investigator
    8. has known or suspected human immunodeficiency virus (HIV) or hepatitis B or C
    9. is pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods with a low failure rate of less than 1% per year (e.g. oral contraceptive, some intrauterine devices, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening and prior to randomisation on Day -1.
    10. is an habitual user of recreational drugs (including amphetamine,
    methamphetamine, cocaine and opiates), and who has used them within
    14 days prior to Screening or has a positive test for drugs of abuse at Screening
    11. has received sodium valproate or topiramate within 30 days of Screening
    12. has a history of a significant medical condition that may affect the safety of the
    patient or preclude adequate participation in the study, including but not limited
    to coronary artery disease, chronic obstructive pulmonary disease, arrhythmias,
    diabetes and epilepsy
    13. has received any investigational drug within 30 days of Screening
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    The number of GERD symptom (heartburn and/or regurgitation) free days in week 2 of study medication (Days 8 to 14) adjusted for baseline will be evaluated. Baseline is defined as the last 7 days prior to randomisation (Day -8 to -2).
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    mechanism of action, tolerability
    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.8.3 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 100
    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 Decision2009-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-16
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