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    Summary
    EudraCT Number:2004-001119-69
    Sponsor's Protocol Code Number:ESCLIN-003/04
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2004-10-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-001119-69
    A.3Full title of the trial
    An evaluation of the dose-response relationship of Cizolirtine citrate 300 mg, twice daily, and 400 mg, twice daily, versus placebo in subjects with urge urinary incontinence.
    A 12-week, randomised, double-blind, placebo-controlled, multicentre study, parallel-group, Phase III clinical study with a 12 months safety follow-up period.
    A.4.1Sponsor's protocol code numberESCLIN-003/04
    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 SponsorLaboratorios Dr. Esteve, SA
    B.1.3.4CountrySpain
    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 namecizolirtine citrate
    D.3.2Product code cizolirtine citrate
    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.3.8INN - Proposed INNcitrato de cizolirtina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcitrato de cizolirtina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typechemical origin
    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
    Urge Urinary Incontinence
    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
    Study Part 1
    The primary objective is to evaluate the efficacy of Cizolirtine citrate, 300 mg, twice daily, and 400 mg, twice daily, versus placebo.

    Study Part 2
    The primary safety objective is to evaluate the long-term (52 weeks) safety of Cizolirtine citrate, 300 mg, twice daily, and 400 mg, twice daily.
    E.2.2Secondary objectives of the trial
    Study Part 1
    The secondary objectives are to
    -evaluate the dose-response relationship between Cizolirtine 300 mg twice daily and 400 mg twice daily
    -evaluate the change in subjective QoL experience of the treatment.
    -evaluate the short term (12 weeks) safety
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Males and females 18 to 75 years of age.
    2. Signed informed consent.
    3. Subjects without any medication, or with ineffective and/or unsatisfactory current medication for OAB, specifically UUI, or subjects with a history of ineffective and/or unsatisfactory medication and currently without medication for OAB (UUI)
    4. Subjects with a history of at least 6 months UUI.

    The subject may be included in the study if all of the criteria at the screening visit along with all of the following criteria at the baseline visit are fulfilled:
    5. Subjects able to co-operate
    6. Subjects able to accurately complete the micturition diary during 7 days in the run-in period.
    7. At least 1 urgency episode/24 h accompanied by at least one incontinence episode/24 h or in average at least 8 micturitions/24 h during 7 days within 14 days prior to the randomisation visit, as quantified from the subject’s micturition diary.
    8. Sterile urine with absence of pyuria as confirmed by dip-stick urine test.
    E.4Principal exclusion criteria
    1. Stress incontinence, or any other reason for incontinence aside from urge incontinence, as determined by the investigator.
    2. Polyuria – more than 40 mL/kg bodyweight per 24 hours.
    3. Concomitant treatment with non-stable doses of drugs that can be supposed to have effects on the lower urinary tract such as antidepressants, neuroleptics, calcium blocking agents.
    4. Any obstructive condition affecting the urethra or any prostatic disease, like benign hypertrophy, neoplasm, or prostatitis of clinical relevance.
    5. Concomitant pharmacological treatment of OAB (UUI) or stress urinary incontinence with any drug different to that of the study. If the subject is using such a drug, it has to discontinued and the screening period extended to three weeks for the subject to be eligible for the study. If oestrogens are administered as treatment for UUI the dose must be stable during at least eight weeks prior to the screening visit for the subject to be eligible for the study, and continued during the study.
    6. Urogenital surgery, such as prostatectomy or a surgical treatment of the incontinence within the last 6 months.
    7. Concomitant conservative treatment for urinary incontinence such as vaginal cones, devices, behavioural therapy, intermittent urinary catheter, electrical stimulation etc.
    8. Hepatic disease (defined as twice the upper limit of the reference range for liver function test).
    9. Renal disease (defined as twice the upper limit of the reference range for creatinine).
    10. Any history of cerebral stroke.
    11. Manifest coronary heart disease.
    12. Uninvestigated haematuria or haematuria secondary to malignant disease.
    13. Interstitial cystitis (diagnosed by symptoms)
    14. Recurrent urinary tract infections defined as four or more confirmed infections treated within 1 year before the screening visit.
    15. Neurological disorder associated with incontinence, e.g. Parkinson’s disease and Multiple Sclerosis.
    16. Unstable diabetes that requires changes of the treatment with either insulin or other anti diabetic agents.
    17. Known allergy or hypersensitivity to study compound or structurally related compounds.
    18. Participation in any other clinical study within one month prior to screening visit or previous participation in the present study.
    19. Drug and/or alcohol abuse.
    20. Any planned major surgery within the duration of the study.
    21. Pregnant or nursing women, and women of childbearing potential not using reliable contraceptive methods.
    22. Any other condition or symptoms preventing the subject from entering the study, according to the investigator’s judgement.

    Neither will the subject be included if one of the following criteria are fulfilled at the baseline visit:
    23. Clinically relevant abnormal values from the laboratory tests on haematology, serum chemistry and urinalysis.
    24. Clinically relevant abnormal ECG as judged by the investigator.
    25. Electrostimulation therapy or bladder training therapy within 2 weeks before baseline visit or planned such therapy during the study.
    26. Any treatment with clean intermittent self catheterisation or indwelling catheter within 2 weeks before baseline visit.
    E.5 End points
    E.5.1Primary end point(s)
    Study Part 1
    The primary efficacy endpoint is the number of incontinence episodes (with or without urgency) per 24 hours as calculated from the subject micturition diaries.

    Study Part 2
    The primary safety endpoints are the number and severity of Adverse Events (AEs)
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 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 2004-10-05. 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Women of childbearing potential must use reliable contraceptive methods
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 450
    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 Decision2004-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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