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    Summary
    EudraCT Number:2005-003391-37
    Sponsor's Protocol Code Number:Scil-MD05-C01
    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:2005-12-08
    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 number2005-003391-37
    A.3Full title of the trial
    Pilot Study on Safety and explorative Efficacy of MD05 in Comparison with the Medical Device Beta-TCP Mixed with Autogenous Bone Material in Patients Undergoing Two-Stage Unilateral Maxillary Sinus Floor Augmentation
    A.3.2Name or abbreviated title of the trial where available
    Sinus Lift Study
    A.4.1Sponsor's protocol code numberScil-MD05-C01
    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 SponsorScil Technology GmbH
    B.1.3.4CountryGermany
    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 MD05
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRadotermin
    D.3.9.1CAS number 575458-75-2
    D.3.9.2Current sponsor coderhGDF-5
    D.3.9.3Other descriptive namegrowth differentiation factor 5 (human), homodimer
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.45
    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) 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 typeThe IMP consists of beta-tricalcium phosphate granules coated with recombinant human GDF-5. It is a powder for suspension for implantation (parenteral drug).
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    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) 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 typeThe comparator is a medical device consisting of resorbable beta-tricalcium phosphate granulate.
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Requirement of two-stage unilateral maxillary sinus floor augmentation in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10061257
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to determine the area of newly formed mineralised bone tissue (%) as assessed by histomorphometry 3 or 4 months after sinus floor augmentation (sinus lift) with either MD05 or the comparative product.
    E.2.2Secondary objectives of the trial
    Secondary objectives are the safety of MD05, bone quality, radiographic bone gain, area of remaining beta-TCP (%) and uneventful healing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients requiring two-stage unilateral maxillary sinus floor augmentation (sinus lift) in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants
    2. Residual bone height at the site of planned implantation > 1 mm and < 5 mm
    3. Male and female outpatients, 18 to 75 years old
    4. Female patients must be infertile (either sterilised or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level > 25 IU/l and absence of menstrual bleeding > 6 months will satisfy the definition of postmenopausal status.
    5. Patient has given informed consent.
    E.4Principal exclusion criteria
    1. Women of childbearing potential, lactating women
    2. Participation in another clinical study within 30 days prior to study start
    3. Previous participation in this study
    4. Last dental extraction (maxilla, posterior to canine) within the last 3 months
    5. Failed sinus lift surgery and previous eradictive maxillary sinus surgery (e.g. Caldwell-Luc surgery)
    6. Simultaneously bilateral sinus lift
    7. Legal incompetence or restricted legal competence
    8. Alcoholism, drug dependency, smoking
    9. Acute or chronic infection at the application site, e.g., sinusitis
    10. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
    11. Severe allergic rhinitis which requires permanent medication
    12. Known intolerance of or hypersensitivity to beta-TCP or rhGDF-5
    13. Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years
    14. Patients requiring chemo- or radiotherapy
    15. Previous or current radiotherapy of the head
    16. Chronic liver disorder (AST and/or ALT over 2 times upper limit of normal)
    17. Impaired renal function (serum creatinine over 1.5 times upper limit of normal)
    18. Uncontrolled, insulin-dependent diabetes mellitus (HbA1c > 7%)
    19. Clinically relevant symptoms of thyroid dysfunction
    20. Severe hypertension (RRdiast > 110 mmHg)
    21. Clinically relevant cardiovascular disease, e.g., decompensated cardiac insufficiency, haemodynamically relevant heart valve defects, or myocardial infarction during the last three months
    22. Systemic bone disease or illness having influence on bone metabolism, e.g. osteogenesis imperfecta, Paget's disease, Ehlers-Danlos disease, osteomalacia, renal osteodystrophia, hyperparathyroidism
    23. Clinically relevant blood coagulation disorder, e.g., haemophilia, thrombocytopenia
    24. Leukopenia < 3.500 leukocytes/µL
    25. Previous (within last 2 months before screening visit) or current treatment with systemic corticosteroids of more than 5 mg/day prednisone equivalent (inhaled glucocorticoids are allowed)
    26. Previous or current therapy with drugs having any influence on bone metabolism such as calcitonin or parathormone (as teriparatid) within the last 6 months before screening visit, bisphosphonates or fluoride at least for 30 days within the last 12 months before screening visit
    27. Previous (within last 2 months before screening visit) or current treatment with immunosuppressant medication
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter of interest is the proportion of the newly formed mineralised bone (%) as assessed by histomorphometry 3 or 4 months after sinus floor augmentation (sinus lift).
    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 Yes
    E.6.7Pharmacodynamic No
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    medical device
    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
    The end of the study is defined as the last visit of the last patient undergoing the trial in the participating member state.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 No
    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 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)
    See study protocol sections 6.15:
    There are no special study-specific provisions for care after the patients have ended the study. Just like for a non-study intervention the patients might be treated by their normal dentist. They might return to the specialist who conducted the study in case problems occur that might have their origin in study-specific interventions.
    See also study protocol section 7.4 for follow up after adverse events.
    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 Decision2005-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-04
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