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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2006-003577-27
    Sponsor's Protocol Code Number:A6631007
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-11
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-003577-27
    A.3Full title of the trial
    A 12-WEEK, PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF PH-797804, ADMINISTERED ORALLY ONCE DAILY IN SUBJECTS WITH ACTIVE RHEUMATOID
    ARTHRITIS.
    A.3.2Name or abbreviated title of the trial where available
    na
    A.4.1Sponsor's protocol code numberA6631007
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numberna
    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 SponsorPfizer Ltd
    B.1.3.4CountryUnited Kingdom
    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.3.2Product code PH-797804
    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.3.9.1CAS number 586414-48-4
    D.3.9.2Current sponsor codePH-797804
    D.3.9.3Other descriptive nameS(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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) 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.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.3.2Product code PH-797804
    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.3.9.1CAS number 586414-48-4
    D.3.9.2Current sponsor codePH-797804
    D.3.9.3Other descriptive nameS(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide
    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) 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.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.3.2Product code PH-797804
    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.3.9.1CAS number 586414-48-4
    D.3.9.2Current sponsor codePH-797804
    D.3.9.3Other descriptive nameS(-)-3-[3-bromo-4-[(2,4-difluorobenzyl)oxy]-6-methyl-2-oxopyridin-1(2H)-yl]-N,4-dimethylbenzamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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
    Treatment of rheumatoid arthritis (RA)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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 this study is to evaluate the safety and tolerability of PH-797804 monotherapy in subjects with active RA on their current treatment regimen and having failed in the past at least 1 DMARD regimen. This will be accomplished in a 2-stage design, with an initial Safety/PK evaluation stage (Stage 1) in the first 50 treated subjects. A successful Stage 1 will launch the second stage (Stage 2) to complete the full enrollment of the study to evaluate the overall safety and tolerability of QD, oral PH-797804 versus placebo in all subjects through 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    1. To compare the efficacy of 4 dose levels of PH-797804 (0.5, 3, 6, and 10 mg QD) versus placebo, administered over 12 weeks for the treatment of the signs and symptoms of subjects with active RA;
    2. To evaluate the PK profiles of multiple doses of PH-797804 administered for 12 weeks to subjects with active RA;
    3. To evaluate the dose- and concentration-response of PH-797804 against measures of disease activity through 12 weeks of treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Has provided written informed consent and is willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;
    2. Is >18 years of age;
    3. Has had at least 1 DMARD regimen failure;
    4. In the last 6 months prior to the Screen visit, has been diagnosed with RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria, ie, fulfilling at least 4 of the following 7 criteria:
    • Morning stiffness in and around any joint for more than 1 hour;
    • Soft tissue swelling of 3 or more joint areas;
    • Swelling of the proximal interphalangeal (PIP), metacarpophalangeal (MCP), or wrist joints;
    • Symmetrical joint swelling;
    • Rheumatoid nodules;
    • Serum rheumatoid factor positive;
    • Radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints.

    5. In their current treatment regimen, maintains a minimum current level of disease activity characterized by:
    • ≥6 joints tender or painful on motion (28-joint count),
    • ≥6 joints swollen (28-joint count), AND
    • C-reactive protein (CRP) ≥1 mg/dL (10 mg/L);

    6. Meets the ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II,
    or III (see Appendix 1of the protocol);
    7. Has observed the washout periods if treated with any of the following therapies:
    • Within 4 weeks of first dose:
    Biologics —anakinra (Kineret®), etanercept (Enbrel®);
    DMARDs —leflunomide (Arava® —see additional washout information for leflunomide in 5.7), auranofin (oral gold), injectable gold (aurothioglucose or
    aurothiomalate), methotrexate, sulfasalazine, and d-penicillamine;
    Immunosuppressive/Immunomodulatory therapies —azathioprine, cyclosporine,
    minocycline, and PROSORBA® device/column;
    NSAIDs —any experimental nonselective or selective NSAID (COX-2 inhibitor)
    within a clinical trial setting with the exception of celecoxib [Celebrex®] for which a
    washout interval of 72 hours shall apply);
    Other —herbal medications, immunization with any live virus vaccination (eg, FluMist®), intra-articular, intramuscular, or intravenous corticosteroids;

    • Within 8 weeks of first dose: infliximab (Remicade®), adalimumab (Humira®);
    • Within 6 months of first dose: abatacept (Orencia®);
    • Within 12 months of first dose: rituximab (Rituxan®), alemtuzab (CamPath®).

    8. If female, has met either of criterion “a.” or “b.” below:
    a. If of nonchildbearing potential, has met 1 of the following criteria:
    • Amenorrheic for at least 2 years, or
    • Has had a hysterectomy and/or bilateral oophorectomy at least 8 weeks prior to
    screening;
    Hence, all other female subjects (including those with tubal ligations) will be considered of childbearing potential.
    b. If of childbearing potential, must be willing to use the acceptable methods of
    contraception and abide by the timelines of each method as outlined in
    Section 4.4.1.1 (protocol);

    9. If male, must be willing to use the acceptable methods of contraception and abide by the timelines as outlined in Section 4.4.1.2 (protocol);
    E.4Principal exclusion criteria
    1. A diagnosis of any other inflammatory arthritis (eg, spondyloarthropathies) or
    fibromyalgia (active RA with secondary osteoarthritis is acceptable);
    2. A history of:
    • Severe, progressive, and/or uncontrolled renal, hepatic, hematological,
    gastrointestinal, endocrine, pulmonary, cardiac, neurological disease within 6 months
    of first dose;
    • Significant associated cardiac disease (eg, prior Coronary Artery Bypass Graft
    [CABG], myocardial infarction, ischemic myocardial disease, congestive heart
    failure, known arrhythmias of ventricular etiology, cardiomyopathy, unexplained
    syncope or syncope/seizures related to arrhythmia);
    • Chronic or recent serious or life-threatening infection within 6 months of first dose;
    • Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified
    Protein Deriviative) without known vaccination with the bacilli Calmette-Guerin
    vaccine (BCG). Refer to Section 7.2.3.1 of the protocol for additional clarification;
    • A positive T-SPOT .TB, where used;
    • Significant trauma or major surgery within 8 weeks of first dose of study medication;
    • Alcohol abuse with less than 6 months of sobriety; drug abuse within 3 years of study start;
    • Cancer, which has been in remission for <5 years excluding subjects with adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    3. Presenting with:
    • Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically
    significant diabetic gastroenteropathy);
    • Any clinically significant skin lesions as described in CTCAE Version 3.0
    (Appendix 2 of protocol);
    • A body temperature >38°C (98.6°F) at Baseline;
    • An infection with human immunodeficiency virus (HIV) or Hepatitis B or C;
    • Any clinically significant active infection including herpes lesions;
    • New York Heart Association (NYHA) Class III-IV congestive heart failure requiring
    treatment (Appendix 3 of protocol);
    • A confirmed mean of the Screen triplicate QTc interval >450 ms;
    • A clinically significant abnormal ECG finding.
    4. Evidence of organ dysfunction or hematopoietic disorder based on any of the following assessments:
    • Hgb <10 gm/dL, Hct <32%;
    • Absolute WBC count <3.0 × 109/L (<3000/mm3);
    • Neutrophil count ≤1.2 × 109/L (<1200/mm3);
    • Platelet count <100 × 109/L (<100,000/mm3);
    • AST (aspartate aminotransaminase), ALT (alanine aminotransaminase) >1.2 ULN;
    • Total bilirubin >1.2 × ULN;
    • Alkaline phosphatase >1.2 × ULN;
    • Albumin <3.5 g/dL or 35 g/L due to known liver disease;
    • Serum creatinine >ULN.
    5. Subjects requiring prohibited concomitant medications (Appendix 4of the protocol);
    6. Pregnant or breastfeeding subjects.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    • Incidence and severity of AEs;
    • Incidence and severity of clinical findings on physical examination;
    • Incidence and severity of clinical laboratory abnormalities;
    • Mean change from Baseline in vital signs (blood pressure [BP], heart rate [HR],
    temperature) measurements;
    • Categorical summary of absolute vital signs and vital signs changes compared to Baseline by subject;
    • Mean change from Baseline in 12-lead ECG parameters; and
    • Categorical summary of absolute ECG parameters and ECG changes compared to
    Baseline by subject. The determination of the primary QTc endpoint will be based on the adequacy of the correction of a potential positive linear relationship between the QT interval and the RR interval.

    Pharmacokinetics:
    Plasma PH-797804 concentrations will be determined by a validated assay.
    Efficacy
    • American College of Rheumatology 20 (ACR20) responder rate at Week 12;
    • ACR20 responder rate at Weeks 1, 2, 4, 8, and 16;
    • ACR50/70 responder rate at Weeks 1, 2, 4, 8, 12, and 16;
    • Tender/painful joint count (28) at Baseline and Weeks 1, 2, 4, 8, 12, and 16;
    • Swollen joint count (28) at Baseline and Weeks 1, 2, 4, 8, 12, and 16;
    • Patient’s Assessment of Arthritis Pain (100 mm visual analog scale [VAS]) at Baseline and Weeks 1, 2, 4, 8, 12, and 16;
    • Patient’s Global Assessment of Arthritis (VAS) at Baseline and Weeks 1, 2, 4, 8, 12,
    and 16;
    • Physician’s Global Assessment of Arthritis (VAS) at Baseline and Weeks 1, 2, 4, 8, 12, and 16;
    • Health Assessment Questionnaire —Disability Index (HAQ-DI) at Baseline and Weeks 1, 2, 4, 8, 12, and 16;
    • C-reactive protein (CRP) at Baseline and Weeks 1, 2, 4, 8, 12, and 16;
    • Disease Activity Score —[DAS28-4 (CRP)] at Baseline and Weeks 1, 2, 4, 8, 12, and 16;
    • Incidence and time to withdrawal due to lack of efficacy;
    • Modified Brief Pain Inventory-Short Form (mBPI-SF) at Baseline and Weeks 1, 2, 4, 8, and 12;
    • SF-36v2 (Acute) Health Survey at Baseline and Weeks 4 and 12.
    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
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 Yes
    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 end of trial is the last visit of the last subject.
    Poor recruitment (recruiting less than the anticipated number in the CTA) by a Member State is not a reason for premature termination but is considered a normal
    conclusion to the trial in that Member State.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days17
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 290
    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)
    na
    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 Decision2006-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-17
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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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