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    Summary
    EudraCT Number:2010-021014-33
    Sponsor's Protocol Code Number:TFM-CL3-001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-06
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-021014-33
    A.3Full title of the trial
    A Phase III, Double-Blind, Placebo Controlled, Parallel Group, International, Multicenter Study of 12 Weeks Treatment with Trafermin 0.01% Spray in Patients with Diabetic Foot Ulcer of Neuropathic Origin.
    A.3.2Name or abbreviated title of the trial where available
    The TRAfermin in Neuropathic diabetic foot ulcer Study - southern Europe. The TRANS-North study
    A.4.1Sponsor's protocol code numberTFM-CL3-001
    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 SponsorOlympus France SAS
    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 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 No
    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 nametrafermin 0.01% spray
    D.3.2Product code OTD-101, KCB-1
    D.3.4Pharmaceutical form Cutaneous spray, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtrafermin
    D.3.9.1CAS number 131094-16-1
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.8Extractive medicinal product Yes
    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 typerecombinant human basic fibroblast growth factor (rh-bFGF) produced with E. coli
    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 placeboCutaneous spray, solution
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10012664
    E.1.2Term Diabetic foot ulcer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care. Wound closure is defined as 100% reepithelialization of the target DFU, without drainage.
    E.2.2Secondary objectives of the trial
    • To determine the time to reach complete wound closure.
    • To determine absolute and relative wound area regression and wound edge migration based on planimetry tracing.
    • To determine the occurrence rate of clinical infection on the target DFU.
    • To evaluate the safety of trafermin 0.01% spray.
    • To determine the rate of amputations on the target DFU.
    • To determine the frequency of local mechanical or surgical procedures.
    • To determine the maintenance of wound closure/time to re-opening up to 3 months after observed reepithelialization.
    • To determine DFU new occurrence/recurrence up to 12 months.
    • To explore biomarkers from target wound fluid (selected centers only).
    • To assess high sensitivity C-Reactive Protein (hs CRP) level variations.
    • To explore the correlation of absolute and relative wound area regression and wound edge migration based on photography in comparison with planimetry tracing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent to participate.
    2. Male or female patients age 18 years or older.
    3. Type 1 or 2 diabetes.
    4. A single full-thickness DFU that has been present for at least 2 weeks.
    5. DFU surface area ≥1 cm2 and ≤20 cm2 confirmed by the investigator’s measurement, and its surface area not decreased by more than 40% compared to the selection value.
    6. No exposure of bone in the target DFU.
    7. Neuropathy confirmed by loss of protective sensation to monofilament test.
    8. Non-infected target foot DFU of confirmed neuropathic origin with confirmed ABPI on the leg with the target DFU ≥0.7 and ≤1.3, and, toe blood pressure >40 mmHg (to exclude predominant ischemia requiring further exploration and treatment).
    9. Completed the 2-week placebo run-in period during which they were compliant to off-loading and to daily application of placebo spray, without major protocol violation. Compliance with the placebo run-in treatment regimen must be “excellent” or “acceptable”.
    10. Glycosylated hemoglobin (HbA1c) ≤10% (from a blood sample taken during the placebo run-in period).
    11. Target DFU appropriately debrided (<10% black and at least 50% of red/pink on a colorimetric scale).
    12. Target DFU of grade A1 or A2 on the University of Texas Wound Classification System or of Grade 1 or 2 of the Wagner classification.
    E.4Principal exclusion criteria
    1. Active Charcot foot, or inactive Charcot foot, if the target DFU cannot be properly offloaded.
    2. Ulcers of non-neuropathic origin (e.g., rheumatoid, radiation-related, vasculitis-related ulcers).
    3. Presence of any foot ulcer (whether or not on the target foot) for which local or systemic antibiotic treatment is required.
    4. Evidence of skin cancer within or adjacent to the target ulcer.
    5. Any infected ulcers, defined as any problem such as (but not limited to) cellulitis, osteomyelitis, gangrene, or deep tissue infection requiring local or systemic antibiotic therapy.
    6. Another wound on the same limb as the target DFU, even if the other wound does not involve the foot.
    7. Any known active malignancy that requires general, local, surgical or radiation therapy either ongoing or within the previous 6 months; or patients whose treatment has been suspended for compassionate reasons, or who are not considered as cured from any malignancy.
    8. Morbid obesity, defined as body mass index (BMI) ≤40 kg/m2.
    9. Clinically significant medical conditions, in the investigator’s opinion, that could impair wound healing (e.g. hepatic impairment, immunocompromised patients).
    10. Severe renal failure, defined as requirement for hemodialysis or peritoneal dialysis.
    11. Females who are pregnant or breastfeeding, or who are of childbearing potential and not practicing a medically approved method of contraception.
    12. Concomitant treatment with high dose oral or parenteral corticosteroids, defined as a daily dose of at least 7.5 mg prednisone or equivalent.
    13. Participation in another clinical study within the previous 3 months.
    14. Current participation in another clinical study with any drug or device.
    15. History of drug or alcohol abuse within the previous year.
    16. Concurrent severe psychiatric disease (including severe depressive disorder).
    17. Known intolerance to the IMP or to any of its excipients.
    18. Known to be uncooperative or noncompliant.
    19. Outpatients who are unable to comply with the requirement for daily spray application at home (either application by a family member or by a visiting nurse).
    20. Any other condition which, in the opinion of the investigator, would render the patient unsuitable for the study.
    E.5 End points
    E.5.1Primary end point(s)
    Wound closure is defined as observed 100% reepithelialization of the target DFU, without drainage, confirmed by a second medical evaluation after two weeks.
    The wound closure rate is the number of patients achieving wound closure at the specified timepoint during the 12-week double blind 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Yes
    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
    End of Trial is defined as last patient last visit in accordance with the protocol. After the double-blind treatment period (max. 12 weeks), patients will be followed up for a total of 9 months from the last treatment application.
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 210
    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 Decision2010-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-06
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