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    Summary
    EudraCT Number:2011-000436-28
    Sponsor's Protocol Code Number:Z102-008
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-10
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-000436-28
    A.3Full title of the trial
    A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, RANDOMIZED WITHDRAWAL DESIGN TRIAL USING ADAPTIVE RANDOMIZATION COMPARING Z102 WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to compare Z102 against placebo in patients with Rheumatoid Arthritis.
    A.4.1Sponsor's protocol code numberZ102-008
    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 SponsorZalicus, Inc.
    B.1.3.4CountryUnited States
    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 supportZalicus, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1000 Continental Drive
    B.5.3.2Town/ cityKing of Prussia
    B.5.3.3Post codePA 19406
    B.5.3.4CountryUnited States
    B.5.4Telephone number+0016109642012
    B.5.5Fax number+0016102250050
    B.5.6E-mailmeera.jessani@wwctrials.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 nameZ102
    D.3.2Product code Z102
    D.3.4Pharmaceutical form Capsule
    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 INNZ102 (Prednisolone and Dipyridamole).
    D.3.9.2Current sponsor codeZ102 (Prednisolone and Dipyridamole).
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number360
    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 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 namePrednisolone
    D.3.2Product code Prednisolone
    D.3.4Pharmaceutical form Capsule
    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 INNPrednisolone
    D.3.9.1CAS number 52438-85-4
    D.3.9.2Current sponsor codePrednisolone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.7
    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 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 nameDipyridamole
    D.3.2Product code Dipyridamole
    D.3.4Pharmaceutical form Capsule
    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 INNDipyridamole
    D.3.9.1CAS number 58-32-2
    D.3.9.2Current sponsor codeDipyridamole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number180
    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 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 Dacortin ®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.4Pharmaceutical form Capsule
    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 INNPREDNISONE
    D.3.9.1CAS number 53-03-2
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 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
    Treatment of patients with moderate to severe rheumatoid arthritis (RA)
    E.1.1.1Medical condition in easily understood language
    Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate the efficacy of Z102 2.7/360 versus placebo on the Disease Activity Score 28 C-reactive protein (DAS28-CRP) in patients with RA at the study endpoint of 12 weeks.
    E.2.2Secondary objectives of the trial
    • Demonstrate the clinical efficacy of Z102 2.7/360 versus the separate components of Z102 (2.7 mg prednisolone and360 mg dipyridamole) and versus 5 mg prednisone, as measured by the DAS28-CRP score, in patients with RA at the study endpoint of 12 weeks

    • Examine the efficacy ofZ102versus its separate components on the secondary outcome measures and assessment tools
    oDAS28-CRP
    oDAS28-CRP individual components
    Tender Joint Count
    Swollen Joint Count
    Patient Global Assessment of Disease Activity
    CRP
    oAmerican College of Rheumatology ACR20, ACR50, ACR70, which includes
    Tender Joint Count
    Swollen Joint Count
    Patient Global Assessment of Disease Activity
    Physician Global Assessment of Disease Activity
    Health Assessment Questionnaire
    Patient Pain Visual Analog Scale
    oMultidimensional Assessment of Fatigue
    oTime to failure addition of a disease modifying anti-rheumatic drug or withdrawal due to flare
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet all of the following inclusion criteria to be enrolled in the study:

    1.Prior to screening have voluntarily signed the informed consent form.

    2.At Screening be at least 18 years of age.

    3.At screening meet the ACR / EULAR criteria for classification of RA(please refer to Section 5.13.2 and/or Appendix B [Section 12.2] for additional details)which include:
    o Joint involvement
    o Serology
    o Acute-phase reactants
    o Duration of symptoms

    4. At screening have moderate to severe RA, defined as involving a minimum (≥6 total swollen and ≥6 total tender) of the 28 joints assessed.

    5. At screening have screening CRP levels of at least 0.6 mg/dl and a DAS28-CRP score ≥4.5.Retesting of the CRP and recalculation of DAS28-CRP (due to CRP <0.6 mg/dL) is allowed one time.

    6. Have been on DMARD therapy for at least 90 days, have been on stable DMARD dose without dosage adjustment or modification for 6 weeks, and should be able to maintain the same dose of conventional DMARD therapy during study participation (with or without glucocorticoid therapy). Stable DMARD therapy may include a combination of DMARD agents (methotrexate and azsulfadine or methotrexate and hydroxychloroquine as examples).

    7. At screening female patients of childbearing potential (18 to 55 years of age, inclusive) must have negative urinary BhCG tests at enrollment and study completion.

    8. Female patients of childbearing potential (18 to 55 years of age, inclusive) must use acceptable methods of birth control (including, but not limited to, IUD, oral or injectable contraceptives, or barrier methods) while in the study.

    9. If currently taking the following medications she/he has been on a stable dose of the same drug for at least 3 months prior to entering into the trial and will continue on the same dose for the duration of the trial: statins, diuretics, thyroid hormone, hypoglycemic medications, and cardiovascular medications.


    E.4Principal exclusion criteria
    1.Female patient is pregnant,actating,or of child bearing potential not using acceptable methods of birth control including,but not limited to,IUD,oral or injectable contraceptives,barrier methods or abstinence
    2.Patients who do not respond to therapies that include a dose < 10mg prednisone and either a DMARD combination,DMARDbiologic combination or biologics alone
    3.Active cardiovascular disease,unless well controlled by appropriate treatment for a minimum of 3months prior to screening
    4. taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325mg
    5.Taking oral steroids at a daily prednisone dose,or the equivalent,of >10mg/day within the past 2weeks
    6.Intraarticular,intramuscular,or intravenous glucocorticoids must not have been given at least 6weeks prior to entering the study or be anticipated to be given at any time during the study
    7.The need to continue the use of one or multiple NSAIDs at the same time,or the use of acetaminophen on a chronic basis.
    Ataminophen/paracetamol will be permitted episodically for pain during the trial,not exceeding 1.5gper day for any 3days in any 7day interval.There are no exclusions during the 30day followup period
    8.All opiate use is prohibited.Such agents include oxycodone,
    hydrocodone,codeine,morphine sulfate,Demerol(meperidine/pethidine),Dilaudid(hydromorphone),combi
    nation products including Percocet(oxycodone and
    acetaminophen),Hydrocet(dihydrocodeine
    andacetaminophen),Tylenol(acetaminophen or paracetamol) with
    codeine,Vicodin(hydrocodone and acetaminophen),Lorcet(hydrocodone and acetaminophen),Lortabs(hydrocodone and acetaminophen)and extended-release formulations
    9.Use of any other medications or herbs or non pharmacological
    treatments eg acupuncutre used for the treatment of pain is prohibited
    10.Excluded medications include Drugs known to interact with dipyridamole(egadenosine, cholinsterase inhibitors,theophylline,caffeine and other xanthine derivatives)or with prednisolone(eganticoagulants,antifungals and HIV protease
    inhibitors)Systemic anticoagulants,including
    dipyridamole,Coumadin(warfarin),clopidogrel,ticlopidine and aspirin
    exceeding 325mg/day(whether or not taken for cardiovascular
    prophylaxis) All Systemic antifungal agents, including but not limited to the polyene macrolides(amphotericin B),the
    azoles(ketoconazole,miconazole,itraconazole and fluconazole) and the allylamines(terbinafine) All antiHIV drugs belonging to the following classes:members of the nucleoside/nucleotide reverse transcriptase inhibitors,nonnucleoside/
    nucleotide reverse transcriptase inhibitors,protease
    inhibitors,fusion and entry inhibitors and integrin inhibitors.These
    agents include but are not limited to abacavir,zidovudine,didanosine,tenofovir and efavirenz
    11.Has,or has had,any active severe infections,such as
    osteomyelitis,sepsis,active infectious hepatitis,endocarditis, systemic fungal infection or recent invasive surgical procedures within 30days of study initiation
    12.Tuberculosis At screening patients with a history of or currently active tuberculosis as per specific country guidelines are excluded Patients with a positive Chest XRay eg apical thickening compatible with TB exposure/latency are excluded
    Patients who have a positive PPD test, in association with compatible signs and symptoms and/or a positive or indeterminate QFT are excluded Note:A patient with a previous positive PPD test is at risk for development of a severe local reaction upon re-exposure.A patient with an established positive PPD result will not be re-challenged,but will
    undergo blood testing using QFT
    Note:If a patient has a documented x-ray within the previous 26weeks then it need not be repeated at screening.The x-ray must be reviewedand commented by a specialist
    13.Has had an invasive malignancy within the past 5years
    14.Has uncontrolled diabetes mellitus at Screening as defined by a
    serum glucose>126 mg/dl.If the result of the glucose test is
    >126mg/dL,then a confirmatory fasting test may be done and if >126 mg/dLthe patient must be excluded
    15.Known HIV,hepatitis B or hepatitis C infection
    16.Has undergone administration of any investigational drug within 30days of study initiation or intention to participate in any
    investigational drug trial during the study
    17.All biologic agents are excluded for 90days prior to Screening and throughout the study
    18.Has undergone administration of rituximab or any Bcell depleting investigational drugs within 6months of Screening
    19.Known or suspected history of alcohol or drug abuse within 2years prior to screening
    20.Any other medical condition which may interfere with the conduct of this study in the opinion of the investigator
    21.Has a history of hypersensitivity reaction to glucocorticoids and or dipyridamole
    22.Has limited mental capacity or language skills such that simple
    instructions cannot be followed or information regarding AEs cannot be provided
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in the DAS28-CRP score at the 12-week visit from the baseline DAS28-CRP pain score. The DAS28-CRP score measured at 4 and 8 weeks will be used by the adaptive modeling in order to learn efficiently about the 12-week effects of each of the treatment arms. A difference between arms of a 0.25 effect (mean change divided by the standard deviation) is considered meaningful for futility analyses. A difference less than this is considered unimportant.

    We label the change from baseline in the DAS28-CRP score for subject i at weeks 4, 8, and 12 weeks as Yi4, Yi8, and Yi12, respectively.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 12.
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Bulgaria
    Chile
    Hungary
    Mexico
    Peru
    Poland
    Russian Federation
    Serbia
    Ukraine
    United States
    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
    Following the last patient-last dose, the completion of the 18 week follow-up of this last patient represents the end of 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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 250
    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)
    Patients who complete 12 weeks of treatment will be invited to participate in a 12 month long term follow up protocol Z102-009.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-14
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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