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    The EU Clinical Trials Register currently displays   34905   clinical trials with a EudraCT protocol, of which   5686   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-001743-21
    Sponsor's Protocol Code Number:BS 594
    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:2007-09-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-001743-21
    A.3Full title of the trial
    A PHASE II DOUBLE BLIND MODIFIED CROSS OVER DESIGN STUDY EVALUATING THE EFFICACY AND SAFETY OF TRIMETAZIDINE (GENERICS UK LIMITED) AND PLACEBO IN THE TREATMENT OF FIBROMYALGIA
    A.4.1Sponsor's protocol code numberBS 594
    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 SponsorGenerics (UK) 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 Yes
    D.2.1.1.1Trade name TRIMETAZIDINE MERCK 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK Génériques
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Coated 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 INNTrimetazidine dihydrochloride
    D.3.9.1CAS number 13171-25-0
    D.3.9.2Current sponsor codeTrimetazidine Merck
    D.3.9.3Other descriptive nameTrimetazidine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 placeboCoated tablet
    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
    Fibromyalgia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    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 demonstrate the efficacy of trimetazidine in subjects with fibromyalgia by testing the hypothesis that the test product trimetazidine is superior to placebo in reducing pain, as determined by the change from baseline of the pain visual analogue score after 10 days treatment.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to further explore efficacy and safety of trimetazidine as compared to placebo in subjects with fibromyalgia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects fulfilling the following criteria are eligible for participation in the study:
    (1) Male or female
    (2) Age equal or more than18 years
    (3) Body weight between 60 and 130 kg for males and 50 and 110 kg for females. In addition the BMI range limit of 18 – 32 kg/m2 (both inclusive) is applicable .
    (4) Diagnosed by an expert as having primary fibromyalgia.
    (5) Newly diagnosed subjects or uncontrolled subjects currently experiencing pain (score > 5 < 8 on the VAS)
    (6) No significant concurrent illness apart from fibromyalgia
    (7) Available for the entire study period and are willing to adhere to the protocol requirements.
    (8) Have signed consent form after the nature of the study has been fully explained.
    E.4Principal exclusion criteria
    Subjects who meet one of more of the following criteria are not eligible:
    (1) History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
    (2) History of autoimmune disease or inflammatory arthropathy (e.g. rheumatoid arthritis, systemic lupus erythematosus) as evidenced either clinically or by serology (elevated rheumatoid factor, antinuclear antibody etc.)
    (3) Clinical and laboratory evidence or history of hepatitis B or C (antibodies)
    (4) Subject is HIV-seropositive
    (5) Change in medication within the last 4 weeks prior to the first administration of the test product and throughout the study
    (6) History of major psychiatric disease.
    (7) Subjects with any other disease, which in the opinion of the investigator is likely to affect the results of the study or subject safety.
    (8) Subjects with screening laboratory test values greater than 2.5 times the normal value.
    (9) Recent history (<1 year) or presence of alcohol abuse or substance abuse. A bit extreme ..no alcohol for a year prior to study?
    (10) History of blood loss exceeding 450 ml (including blood donations) within 1 month before the study.
    (11) Use of any other experimental drug within the previous 3 months prior to first dose and throughout the study.
    (12) Not willing or able to provide written informed consent for participation in the study after being informed by the investigator about the aim, course and possible risks of the study.
    (13) Not willing to give consent for transmission of personal "pseudonymised" data
    (14) Not willing and able to use a contraceptive method, which the investigator considers reliable. Reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence. Women must use reliable methods from 6 weeks before the first administration of test product until 3 weeks after the last administration of the study medication. Men and their female partners must use reliable methods from the first administration of test product until 3 weeks after the final examination. Methods for men are condoms, sexual abstinence and sterilization.
    (15) For females: pregnancy or lactation
    (16) Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline on the pain visual analogue score of the mean pain measured over the last 3 days of the treatment period.
    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 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 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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Last visit of last subject.
    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 months2
    E.8.9.1In the Member State concerned days
    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 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 state30
    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)
    Drug treatment and medical care given to the subject after the end of the study is the responsibility of the subject's own physician.
    The subjects will have the possibility of compassionate use of the study medication after the end of the study. If the subject decides to continue with the study medication he/she will be transferred to his/her primary care physician, who will decide if a continuation of the medication is indicated.
    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 Decision2007-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-11-02
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