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    Summary
    EudraCT Number:2005-001143-31
    Sponsor's Protocol Code Number:CNS-242 Ph2/2
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-05-06
    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 number2005-001143-31
    A.3Full title of the trial
    A Phase II, Multicentre, Double-blind, Parallel Group 8 Week Study to Assess the Efficacy and Safety of Two Doses of CNS-242 in Lowering Serum Uric Acid (SUA) and Preventing Gout Attacks in Gout Patients
    A.4.1Sponsor's protocol code numberCNS-242 Ph2/2
    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 SponsorNippon Suisan Kaisha, Ltd
    B.1.3.4CountryJapan
    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 Information not present in EudraCT
    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 nameCNS-242
    D.3.2Product code CNS-242
    D.3.4Pharmaceutical form Tablet
    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.3.9.2Current sponsor codeCNS-242
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 placeboTablet
    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
    Gout/Hyperuricaemia
    MedDRA Classification
    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 objectives of this study are:
    • To assess the efficacy of CNS-242, after 8 weeks’ treatment, in reducing SUA as a surrogate marker of gout (reduction of SUA to a level of 6 mg/dL).
    • To assess the safety and tolerability of multiple doses of CNS-242 in patients with previous gout attacks and hyperuricaemia.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To assess the change from baseline in SUA after 8 weeks’ treatment with CNS-242.
    • To determine and compare the number of patients experiencing acute attacks of gout during 8 weeks’ treatment with CNS-242.
    • To determine any reduction in tophi after 8 weeks’ treatment with CNS-242.
    • To determine any reduction in levels of pain during and after 8 weeks’ treatment with CNS 242.
    • To assess patient quality of life during and after 8 weeks’ treatment with CNS-242.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To be eligible for inclusion into the study, each patient must fulfil all of the following criteria:

    1. Adults aged at least 18 years.
    2. Patients with pharmacologically controlled gout, defined as:
    • at least one previous documented clinical diagnosis of an attack, but no attack in the 6 months prior to screening, of acute arthritis of the first metatarsal phalangeal joint of the big toe, tenderness and swelling
    3. Levels of SUA ≤ 8 mg/dL at the screening visit, prior to the start of the wash out period. All other clinical laboratory tests within normal ranges and acceptable to the investigator.
    4. Patients under a stable anti-hyperuricaemic treatment with allopurinol, probenecid or sulfinpyrazone in the month before screening.
    5. Willing and able to give written informed consent prior to any study-specific screening procedures and comply with the study protocol for the duration of the study.
    E.4Principal exclusion criteria
    Patients are not eligible for this study if they fulfil one or more of the following conditions:

    1. Patients who are pregnant or breast-feeding. Women of child-bearing potential must be willing and able to use an adequate method of contraception during the course of the study and must have a negative pregnancy test prior to receiving study drug.
    2. Acute gout attack in the 6 months before screening.
    3. Use of colchicine in the month prior to screening. Patients meeting this criterion at the screening visit can re-attend for a second screening visit.
    4. Use of NSAIDs within 2 weeks of screening. Patients meeting this criterion at the screening visit can re-attend for a second screening visit.
    5. Have a clinically relevant history or presence of gastrointestinal, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological or connective tissue diseases or disorders, including hepatic insufficiency (transaminases > 5 x upper limit of normal) and renal insufficiency (CrCl < 30 ml/min) which, in the opinion of the investigator, makes the patient unsuitable for the study.
    6. Have a clinically relevant ECG abnormality.
    7. Have congestive heart failure, New York Heart Association class III and IV.
    8. Have any malignancies in the previous 5 years, with the exception of basal cell carcinoma (excised).
    9. Have a clinically relevant surgical history.
    10. Have a history of alcoholism or drug abuse.
    11. Have used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
    12. Have previously received CNS-242.
    13. Patients who, in the opinion of the investigator, are not able to comply with the protocol, are poor medical candidates or pose a psychiatric risk for therapy with an investigational drug.
    14. Unwilling or unable to give written informed consent.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy analysis population will be used for the primary analysis of the primary endpoint.

    The primary endpoint is the proportion of patients with a reduction of SUA to a level of 6 mg/dL or below. It is considered that if more than 50% of patients in either dose group achieve SUA ≤ 6 mg/dL after 8 weeks’ treatment this will be indicative of a pharmacological effect in an accepted surrogate marker for gout, and worth exploring in a more formal dose finding study. Therefore the efficacy of CNS-242 will be examined via null hypotheses for each dose of the form.

    H0; The proportion of subjects in the CNS-242 dose group with SUA ≤ 6 mg/dL at Visit 5 is < 50%.
    HA; The proportion of subjects in the CNS-242 dose group with SUA ≤ 6 mg/dL at Visit 5 is ≥ 50%.

    The proportion of patients with reduction of SUA to a level of 6 mg/dL or below (successes) will be summarised using tables of frequencies and other descriptive statistics. The null hypothesis will be tested by calculating the exact two-sided probability of the actual proportion of successes, given a binomial distribution with expected proportion of 50%.

    Patients not experiencing an initial increase in SUA to levels above 7 mg/dL (from Visit 1 to Visit 2) will be excluded from the above primary analyses of the primary endpoint.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-05-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 90
    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 Decision2005-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-02-03
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