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    Summary
    EudraCT Number:2007-005784-10
    Sponsor's Protocol Code Number:A6301083
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-14
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-005784-10
    A.3Full title of the trial
    A 6 MONTH, PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF FRAGMIN IN THE TREATMENT OF CHRONIC NEUROISCHAEMIC FOOT ULCERS IN DIABETIC PATIENTS
    A.4.1Sponsor's protocol code numberA6301083
    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 SponsorPfizer Limited, Ramsgate Road, Sandwich, Kent,CT13 9NJ,UK
    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 Fragmin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    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 PNU-180524E
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDalteparin sodium
    D.3.9.1CAS number 9041-08-1
    D.3.9.2Current sponsor codePNU-180524E
    D.3.9.3Other descriptive nameFragmin
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000 IU/0.2
    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 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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Foot Ulcer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    Evaluate the effect of dalteparin compared to placebo on the healing of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy, as determined by the number of patients who have ≥50% reduction in ulcer surface area including intact skin healing after a maximum of 6 months of treatment.
    E.2.2Secondary objectives of the trial
    The key secondary objectives are to evaluate the number of diabetic subjects with chronic neuroischaemic foot ulcers who had intact skin healing. The number of subjects who have required an amputation within the 6 month treatment period will also be investigated. The safety and tolerability of dalteparin compared to placebo in treatment of diabetic patients with neuroischaemic foot ulcers will also be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects ≥18 years of age.
    2. Subjects with type 1 or type 2 diabetes.
    3. Subjects with peripheral arterial occlusive disease (PAOD) who have the following:
    • Thorough clinical assessment by the treating clinical team to exclude all other available PAOD treatment options (ie, revascularization etc)
    • Toe/arm blood pressure index ≤0.8.
    4. Subjects must have a neuropathy disability score (NDS) of ≥3.
    5. Subjects with chronic foot ulcers (defined as an ulcer for >2 months) and an ulcer area between 25-2500 mm2. All ulcers must have an ulcer staging of 1C and 2C according to the University of Texas wound classification system.
    6. Subjects must be on a minimum of 75 mg of aspirin (or equivalent dose of calcium carbasalate or other acetylsalicylic acids) daily for at least 4 weeks prior to randomization and the aspirin/ calcium carbasalate or other acetylsalicylic acid therapy must be continued for the entire duration of the study.
    7. Subjects with ulcer infections at screening as assessed by the presence of clinical signs of infection must be treated with appropriate antibiotics (in accordance to any available bacterial culture and sensitivity pattern results) prior to randomization.
    8. Subjects must be willing to comply with the protocol, scheduled visits, laboratory
    tests and medication regimen.
    9. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    E.4Principal exclusion criteria
    1. Subjects who have undergone vascular reconstruction or angioplasty less than 1 month prior to randomization.
    2. Subjects with an ulcer grading of 0 or 3 or staging of A, B or D according to the
    University of Texas wound classification system.
    3. Subjects with a known bleeding disorder or evidence of active bleeding.
    4. Subjects who are on dialysis.
    5. Subjects with hepatic dysfunction defined as an International normalized Ratio (INR) >2.0.
    6. Subjects with proliferative diabetic retinopathy that in the investigators opinion will
    result in an increased risk of hemorrhage if treated with dalteparin.
    7. Subjects who have undergone a major organ transplant and/or treatment with
    immunosuppressive agents.
    8. Subjects who have participated in a study of an investigational drug or device within four weeks of study entry.
    9. Subjects with malignant ulcers, all subjects with clinically suspicious ulcers will
    require a biopsy to exclude a malignancy prior to enrollment.
    10. Female subjects who are pregnant, lactating, or planning a pregnancy during the
    course of the study, or who are of child bearing potential and not using an acceptable method of birth control. Female subjects should continue contraceptive methods during the study and for at least 30 days after receiving their last treatment.
    11. Subjects treated with anticoagulants or anti-platelet therapy (other than aspirin/ or calcium carbasalate) such as warfarin, clopidogrel, or low molecular weight heparins.
    12. Abuse of alcohol and/or any other drug in the opinion of the investigator.
    13. Subjects with contraindications to dalteparin administration, which include:
    • Known hypersensitivity to the active ingredient in dalteparin or to any of the
    excipients of this product.
    • History of confirmed or suspected immunologically mediated heparin induced
    thrombocytopenia.
    • Severe hypertension.
    • Acute gastroduodenal ulcer, cerebral hemorrhage or known hemorrhagic diathesis.
    • Subacute endocarditis.
    • Injuries to and operations on the central nervous system, eyes and ears (within the last month).
    14. Subjects with any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the following:

    • Number of subjects with ≥50% reduction in ulcer surface area including intact skin
    healing.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 645
    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 Decision2008-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
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