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    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2011-005254-53
    Sponsor's Protocol Code Number:BKOS-03
    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:2012-02-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-005254-53
    A.3Full title of the trial
    A double-blind, randomised, placebo controlled, sequential ascending dose study, to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intra-articular doses of fasitibant in patients with symptomatic osteoarthritis of the knee.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A placebo-controlled study assessing the tolerability and plasma concentrations of ascending doses of fasitibant in patients with osteoarthritis of the knee.
    A.3.2Name or abbreviated title of the trial where available
    ALBATROSS-2
    A.4.1Sponsor's protocol code numberBKOS-03
    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 SponsorMenarini Ricerche S.p.A
    B.1.3.4CountryItaly
    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 supportMenarini Ricerche S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMenarini Ricerche S.p.A
    B.5.2Functional name of contact pointClinical Research Director
    B.5.3 Address:
    B.5.3.1Street AddressVia Sette Santi 1
    B.5.3.2Town/ cityFLORENCE
    B.5.3.3Post code50131
    B.5.3.4CountryItaly
    B.5.4Telephone number003905556809933
    B.5.5Fax number00390555680597
    B.5.6E-mailacapriati@menarini-ricerche.it
    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 nameFasitibant chloride bis-hydrochloride
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFasitibant chloride (as bis-hydrochloride)
    D.3.9.1CAS number 883969-00-4
    D.3.9.2Current sponsor codeMEN 16132
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 nameFasitibant chloride bis-hydrochloride
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFasitibant chloride (as bis-hydrochloride)
    D.3.9.1CAS number 883969-00-4
    D.3.9.2Current sponsor codeMEN 16132
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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 nameFasitibant chloride bis-hydrochloride
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFasitibant chloride (as bis-hydrochloride)
    D.3.9.1CAS number 883969-00-4
    D.3.9.2Current sponsor codeMEN 16132
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 HYALART
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA Pharma GmbH&Co.KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSodium hyaluronate
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Hyaluronate
    D.3.9.1CAS number 9067-32-7
    D.3.9.4EV Substance CodeSUB14126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ostoarthritis of the knee
    E.1.1.1Medical condition in easily understood language
    Degeneration of the cartilage of the knee joint.
    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 LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    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 safety and tolerability of fasitibant up to 5 mg formulated as 1 mL solution to be given as single intra-articular (IA) administration to patients with knee osteoarthritis.
    E.2.2Secondary objectives of the trial
    1) To assess main plasma pharmacokinetic parameters, including dose-proportionality of fasitibant monocomponent (up to 5 mg), of its main metabolite MEN 19148, and of fasitibant 5 mg in extemporaneous combination with sodium hyaluronate in patients with knee osteoarthritis (OA).
    2) To evaluate changes in plasma or serum levels, as appropriate,of OA biomarkers and preliminary efficacy data in knee OA patients following IA single up to 5 mg doses of fasitibant alone and in combination with Sodium Hyaluronate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent.
    2.Male or female patients ≥ 30 years old and a BMI < 30 kg/m².
    3.Women of childbearing potential are eligible to participate in the study if their pregnancy test is negative at screening, they are not nursing, and they use an effective method of contraception.
    4. Symptomatic primary or secondary knee osteoarthritis for which IA treatment is indicated.
    5. Pain score >5 points assigned to the index knee at WOMAC NR 3.1-A1.
    6. Pain score >12 points assigned to the index knee at WOMAC NR 3.1 A subscore. 7. Pain in the index knee on at least 50% of the days in the month preceding the screening.
    8. Minimum flexion of 90 degrees in both knees.
    9. Ability to perform the 15 m walk test without the support of crutches or other assistive devices.
    10. Willingness to discontinue all pain or OA medication.
    11. Willingness to refrain from paracetamol use 48 hours prior to each study visit.
    E.4Principal exclusion criteria
    1. Inability to personally provide written informed consent.
    2. Inability to understand or collaborate throughout the study.
    3. Patients who participated in another clinical trial within 30 days prior randomisation.
    4. Patients with severe OA of the knee.
    5. Knee condition representing an indication for surgery .
    6. Inflammatory or crystal arthropathies.
    7. Patients with acute fractures, severe loss of bone density, bone necrosis.
    8. Patients with isolated patella-femoral syndrome or chondromalacia.
    9. Patients with OA predominant in the lateral compartment.
    10. Patients with any other clinically significant and unstable disease or condition interfering with the evaluation of the safety of study treatment.
    11. Major injury or surgery to the index knee within the previous 12 months prior to screening.
    12. Severe hip OA ipsilateral to index knee.
    13. Any pain >3 points in the numerical rating (NR) scale (0-10) that could interfere with the assessment of the index knee pain.
    14. Any pharmacological or non-pharmacological treatment started or changed during 4 weeks prior to randomisation.
    15. Use of systemic or topical corticosteroids >10 mg prednisolone equivalent.
    16. Use of any pain or OA medication.
    17. Any acute or newly diagnosed disease/condition requiring treatment.
    18. Any unstable chronic disease/condition requiring treatment modification.
    19. History of hypersensitivity to drugs including paracetamol.
    20. Patient with known hypersensitivity to hyaluronate preparations.
    21. Patients with any of the following
    a) clinically relevant cardiovascular, pulmonary, gastrointestinal, haematological, neurologic-psychiatric or infectious diseases.
    b) clinically relevant abnormal safety laboratory test result and/or clinically relevant abnormalities in vital signs and/or ECG parameters at screening (Visit 1) and/or prior to dose administration (Visit 2).
    22. Patients with liver disease
    23. Patients with moderate or severe renal insufficiency (Creatinie Clearence [CrCl according to Cockgroft-Gault formula] < 60 mL/min).
    24. Any sign of significant inflammation or infection.
    25. Any skin disorder or infection overlying the index knee.
    26. Previous infection of the index knee.
    27. Any IA or local peri-articular punction, injection, or surgery to the index knee during the 3 months prior to screening.
    28. Patients with bleeding diathesis or on therapy with anticoagulants.
    29. Significant peri-articular calcification.
    30. Previous ligament reconstruction at the index knee.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of study treatments:
    -Changes in vital signs (blood pressure, pulse rate, respiratory rate, body temperature; 12-lead electrocardiogram (ECG) parameters; laboratory safety battery tests, and physical examination at End of Study versus baseline.
    -Incidence and severity of adverse events occurring between randomisation and End of Study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between randomisation (T0) and two weeks after administration of study treatments (T14 +/- 2 Days).
    E.5.2Secondary end point(s)
    Pharmacokinetics of the study treatments in terms of absorption, distribution, metabolism and elimination of the study treatments, including analysis of dose proportionality.
    This includes also the pharmacokinetic analysis of the main metabolite of fasitibant (MEN 19148), the mono-hydroxylated derivative formed by oxidative metabolism by the cytochrome P450 enzyme.

    Pharmacodynamics of the study treatments:
    Analysis of Biomarkers of osteoarthritis, inflammation and cartilage degeneration.

    Clinical Efficacy of study treatments:
    Assessment of OA symtoms (pain, walking pain, stiffness) using validated standard questionnaires (WOMAC 3.1 NR).
    Assessment of pain at rest and after 15 metres walk
    Patients' and Physicians' global assessment of efficacy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetics:
    Between time of dosing (T0) and defined time points until 1 week (T7 +/-2 days) after treatment adminsitration.

    Pharmacodynamics:
    OA Biomarkers: Between time of dosing (T0) and 1 week (T7 +/-2 days) after treatment adminsitration.

    Clinical Efficacy:
    Between time of dosing (T0), 1 week (T7 +/-2 days) and 2 weeks (T14 +/-2 days) after treatment adminsitration.

    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics of fasitibant (up to 5 mg) and its main metabolite MEN 19148 in humans
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Sequential cohorts:fasitibant 1, 2.5, 5mg vs placebo; fasitiband5mg+hyaluronate (HA) vs placebo+HA
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparison Fasitibant 5mg+Hyaluronate 20mg vs Placebo+Hyaluronate 20mg (to assess additive effects)
    E.8.2.4Number of treatment arms in the trial4
    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 EEA4
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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.1.1.1In 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 60
    F.4.2.2In the whole clinical trial 60
    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)
    Standard medical care of knee osteoarthritis according to the investigators' judgement to be applied after patients have terminated the study.
    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 Decision2012-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-01
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