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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-020973-18
    Sponsor's Protocol Code Number:L00006CP405
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-27
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-020973-18
    A.3Full title of the trial
    “Effect of treatment with ossein-hydroxyapatite compound on the time of fracture-healing”. A prospective, multicenter, double-blind, randomised, placebo controlled clinical trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of treatment with ossein-hydroxyapatite compound on the time of fracture-healing.
    A.4.1Sponsor's protocol code numberL00006CP405
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPIERRE FABRE MEDICAMENT
    B.1.3.4CountryFrance
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointAnne Maret
    B.5.3 Address:
    B.5.3.1Street Address45, place Abel Gance
    B.5.3.2Town/ cityBoulogne
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 534 50 62 13
    B.5.5Fax number+33 534 50 62 20
    B.5.6E-mailanne.maret@pierre-fabre.com
    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 OSTEOGENON
    D.2.1.1.2Name of the Marketing Authorisation holderPierre Fabre Médicament Polska Sp. z.o.o
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameOSTEOGENON
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNOssein hydroxyapatite compound
    D.3.9.2Current sponsor codeL0006
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number830
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    D.3.11.9Recombinant medicinal product No
    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 placeboFilm-coated 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
    Wrist fracture
    E.1.1.1Medical condition in easily understood language
    Wrist fracture
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10061959
    E.1.2Term Fracture treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to compare the effect of a treatment with ossein-hydroxyapatite compound (L0006CP) versus a placebo on the time of fracture-healing in patients with a wrist fracture.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - To assess the effect of the L0006CP on :
    - the functional improvement of upper limb,
    - the reduction of the time of return to normal function,
    - To evaluate safety and tolerability of L0006CP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be included in the trial, patients should fulfill the following criteria:
    - male or menopausal female between 50 and 80 years of age,
    - a recent closed Colles’ fracture (< 48 hours ), correctly reduced and stabilised with Kirschner wires,
    - willing, able to understand and sign an approved Informed Consent Form,
    - able to understand the protocol and to come to the control visits,
    - registered with a social security or health insurance system (if applicable).
    E.4Principal exclusion criteria
    Patients fulfilling at least one of the following criteria cannot be included in the study:

    - a criterion connected to pathologies:
    - Patient with an open fracture,
    - Patient with a bilateral Colles’ fracture or multiple concurrent fractures or injuries,
    - Patient with fracture which may require a surgical treatment during the study treatment,
    - Patient having had a fracture of the upper limb or a prolonged immobilization during the 12 months preceding the inclusion,
    - Patient having had a functional impairment of the hand or the forearm before injury,
    - Patient with a pathological fractures related to cancer,
    - Patient with hereditary bone disease,
    - Patient with bone necrosis,
    - Patient with chronic renal failure or chronic kidney disease or history of renal calculi,
    - Patient with history of calcium metabolism disorders (hypercalcemia, hypocalcemia…),

    - a criterion connected to previous or concomitant treatment:
    - Patient receiving or have received treatment by chemotherapy, radiotherapy, immunosuppressive or systemic steroid treatment within 6 months prior to the inclusion visit,
    - Patient receiving or expected to receive during the course of the study any medication (other than study medication) which might alter bone metabolism: Calcium and phosphate preparations, calcitonin, hormone replacement therapy, anabolic agents, parathormone, heparins (long term treatment), barbiturates, hydantoin, insulin, thiazides,
    - Patient with a known allergy to the study medication or one of its constituents,
    - Patient requiring regular or intermittent steroid therapy.

    - a criterion connected to the study population:
    - Patient with a body mass index (BMI) greater than 34,
    - Patient with generalized rheumatic disease (rheumatoid arthritis, osteoarthritis…) which could impair severely the joint function of the upper limbs,
    - Patient with concomitant disease known to delay the time of frature-healing such as diabetes, respiratory insufficiency, anaemia, vascular insufficiency, thrombophlebitis….
    - Patient with an inflammatory bowel disease or any digestive disease which could modify calcium absorption,
    - Patient with known history of lactose intolerance, hereditary galactose intolerance, the Lapp lactase deficiency or glucose / galactose malabsorption
    - Patient with a severe acute or chronic disease which the investigator deems incompatible with study implementation,
    - Patient with a disease which the investigator considers likely to interfere with the study results or to expose the patient to additional risk,
    - Patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion,
    - Patient having taken part in a clinical trial in the preceding 30 days or taking part in a trial at the time of inclusion,
    - Patient linguistically or psychologically unable to understand and sign the consent form,
    - Patient who has forfeited his freedom by administrative or legal award, or who is under guardianship.
    E.5 End points
    E.5.1Primary end point(s)
    Primary criterion will be the comparison between the 2 treatments of the time to cortical bridging of three cortices in the 2 groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4, Week 6, Week 7 , Week 8, Week 10 and Week 12.
    E.5.2Secondary end point(s)
    Time to cortical bridging of 2 and 4 cortices.
    Time to disappearance of fracture line.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, Week 6, Week 7 , Week 8, Week 10 and Week 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned9
    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 No
    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
    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 years0
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.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)
    usual treatment
    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 Decision2011-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-20
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