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    Summary
    EudraCT Number:2004-000630-37
    Sponsor's Protocol Code Number:308601
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-23
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-000630-37
    A.3Full title of the trial
    A multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the safety, tolerability and efficacy of the CCR1 antagonist ZK 811752, given orally in a dose of 600 mg three times daily, for the treatment of endometriosis over 12 weeks.
    A.4.1Sponsor's protocol code number308601
    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 SponsorSchering Nordiska AB
    B.1.3.4CountrySweden
    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.3.2Product code SH T 00397H
    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 codeZK811752
    D.3.9.3Other descriptive nameBenzur sulfate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 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
    Endometriosis associated pelvic pain
    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
    Safety, tolerability and efficacy of ZK 811752 compared to placebo given orally three times daily over 12 weeks in the treatment of endometriosis associated pelvic pain
    E.2.2Secondary objectives of the trial
    - Change of endometriosis associated pelvic pain every 4 weeks throughout the treatment period
    - Change of intake of rescue medication
    - Change of the Biberoglu and Behrman severity profile for symptoms and finding between baseline and end of treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent.
    2. Women between 18 and 45 years of age, inclusive
    3. Pain associated with histologically proven endometriosis as determined by diagnostic laparoscopy or laparotomy within 24 months prior to start of treatment (Baseline, Visit 2) but no later than 6 weeks prior to Screening (Visit 1)
    4. Threshold for pelvic pain score: minimum 40 mm on VAS at Screening (Visit 1) and at Baseline (Visit 2)
    5. Women with cyclic menstrual bleeding
    6. Normal cervical smear within the last 6 months according to PAP classification
    7. Good general health (except for findings related to endometriosis, with or without infertility)
    8. Willingness to use a barrier contraceptive method (unless bilateral tubal ligation has been performed previously), but no hormonal contraception
    9. Willingness to use only up to 3 Ibuprofen 400 tablets as pain killer for endometriosis-associated pelvic pain
    E.4Principal exclusion criteria
    1. Pregnancy, lactation (at least three cycles have to follow delivery, abortion or lactation before start of treatment)
    2. Amenorrhea of more than 1 cycle within 3 months prior to study start
    3. Bearing of an intra-uterine device (IUD, either hormonal or non-hormonal)
    4. Signs and/or symptoms of therapy-resistent endometriosis despite various attempts of drug treatment or extensive surgical therapy
    5. Need for primary surgical treatment of endometriosis according to the investigator
    6. Previous / current use of hormonal agents including
    - GnRH agonists and depot contraceptives within 6 cycles prior to screening
    (Visit 1)
    - Progestins and danazol within 3 cycles prior to screening (Visit 1)
    - Hormonal contraception within 1 cycle prior to screening (Visit 1)
    - Phytoestrogen intake must be stopped at screening (Visit 1)
    7. Significant, incompletely-healed preexisting illnesses for which it can be assumed that absorption, distribution, metabolism, elimination, and effects of the investigational product will not be normal (e.g. gastrointestinal, autoimmune, signs for immune deficiency)
    8. No actual or history of cardiovascular disorders
    9. Family history of long QT-syndrome
    10. Clinically relevant ECG findings, in particular prolonged QT interval (QT interval after Bazett’s correction for heart rate >440 msec and signs of ventricular hypertrophy at screening (Visit 1)
    11. Abnormal baseline laboratory values that are beyond inclusion range, as defined by the Sponsor or that are considered clinically significant by the investigator
    12. Conditions or medications that are prone to electrolyte changes (e.g. hypokalemia, hypomagnesemia)
    13. Treatment with drugs that are potent inductors or inhibitors of CYP3A4 or drugs that are predominantly metabolised via CYP3A4, 2C9 or 2C19 and the increased plasma levels or prolonged action of which may lead to potentially serious side effects (see attachment no. 3 to the protocol)
    14. Treatment with drugs that prolong the QT interval or increase the risk for hypokalemia (see attachment no. 3 to the protocol)
    15. Intake of grapefruit or grapefruit juice
    16. Clinically relevant findings at gynecological examination
    17. History or suspicion of cancer or precancerous lesions of any type
    18. Positive HIV test, positive hepatitis serology
    19. Metabolic disturbances (particularly severe disturbances of lipid metabolism, insulin-dependent diabetes mellitus, uncontrolled thyroid disorders)
    20. Vital signs (after resting for at least 10 minutes, sitting position)
    - Systolic blood pressure > 140 mm Hg
    - Diastolic blood pressure > 90 mm Hg
    - Heart rate < 50 / min or heart rate > 100 / min
    21. Known allergic reactions to constituents of the galenic formulation (Kollidon SR, lactose, fumaric acid, silicon dioxide, magnesium stearate, hydroxy propyl methyl cellulose, talcum, titanium dioxide and ferric oxide pigment), or to Ibuprofen
    22. Wash out periods to be maintained before start of study medication:
     Less than 5 half life times following the treatment with drugs that may prolong the QT interval or increase the risk for hypokalemia or that are potent inductors or inhibitors of CYP3A4 or drugs that are predominantly metabolized via CYP3A4, 2C9, or 2C19 and the increased plasma levels or prolonged action of which may lead to potentially serìous side effects (see attachment)
     Less than two weeks following the use of chinidine and budipine and the first administration of the study drug
     Less than one day following the intake of colestyramin, colestipol, or of active charcoal (so as not to endanger absorption of ZK 811752).
     Less than two weeks have passed since last intake of grapefruit juice or grapefruit products and first intake of the investigational product
    23. Current or history of clinically significant depression in the last year
    24. History or suspicion of drug and/or alcohol abuse within the last 2 years
    25. Scheduled surgery within the treatment period
    26. Participation in another clinical trial within 1 month or intake of any investigational drug within the last 6 months prior to Screening or participation in any clinical trial during the whole duration of this study
    27. Unwillingness to comply with study procedures or incapability of understanding them, or physical / psychological characteristics of the patient, which, in the opinion of the investigator, may interfere with the perception of pain (e.g., hysteria, neurosis)
    28. Other criteria which, in the opinion of the investigators performing the pre-study examination, preclude participation for scientific reasons of compliance or for reasons of patient’s safety.
    29. Patient is a dependent person, e.g. a relative, family member and/or is a member of the investigator’s staff
    E.5 End points
    E.5.1Primary end point(s)
    Individual absolute change of endometriosis associated pelvic pain between baseline and end of treatment evaluated by a composite parameter of both change of Visual Analog Scale and change of intake of rescue medication due to endometriosis-associated pelvic pain
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    rescue medication allowed for pain (ibuprofen)
    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 No
    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 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
    Last patient last visit
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 2005-09-23. 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 116
    F.4.2.2In the whole clinical trial 116
    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)
    Not expected to be different
    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 Decision2005-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-02-15
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