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    Summary
    EudraCT Number:2008-001376-73
    Sponsor's Protocol Code Number:INN-TOP-003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-10-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-001376-73
    A.3Full title of the trial
    A Randomized, Controlled, Open-Label Study to Investigate the Safety and Efficacy
    of a Topical Gentamicin-Collagen Sponge (Collatamp® G) in Combination With
    Antimicrobial Therapy Compared to Antimicrobial Therapy Alone in Diabetic
    Patients with Moderately Infected Lower Extremity Skin Ulcers
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberINN-TOP-003
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorInnocoll Technologies
    B.1.3.4CountryIreland
    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 namegentamicin collagen sponge
    D.3.4Pharmaceutical form Medicated sponge
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGentamicin Sulfate
    D.3.9.1CAS number 1404-41-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50, to 200
    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 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.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 Yes
    D.2.1.1.1Trade name Tavanic (levofloxacin)
    D.2.1.1.2Name of the Marketing Authorisation holderHoechst Marion Roussel Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTavanic
    D.3.4Pharmaceutical form Film-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 INNLevofloxacin
    D.3.9.1CAS number 100986-85-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic patients with a moderate infection of a lower extremity skin 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
    To determine the effect of the Collatamp G® Topical
    Gentamicin-Collagen Sponge (gentamicin sponge) in combination with
    antimicrobial therapy compared to antimicrobial therapy alone on
    patients’ clinical outcome in the treatment of moderately infected skin
    ulcers
    E.2.2Secondary objectives of the trial
    • To determine the effect of the gentamicin sponge in combination with
    antimicrobial therapy compared to antimicrobial therapy alone on
    eradication of wound pathogens
    • To assess the effect of the gentamicin sponge in combination with
    antimicrobial therapy compared to antimicrobial therapy alone on
    absolute and percent decrease of total wound surface area
    • To assess the safety and tolerability of the gentamicin sponge in
    combination with antimicrobial therapy
    • To assess the systemic exposure to gentamicin following the
    administration of the gentamicin sponge by measuring serum
    gentamicin concentrations in a subset of patients at various time points
    after applying the gentamicin sponge
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Is a man or woman aged ≥ 18 and ≤ 80 years.
    2. Has diabetes mellitus, according to the American Diabetes
    Association criteria.
    3. Has a single infected skin ulcer below the knee, defined as
    “moderate” by the Infectious Disease Society of America (IDSA)
    Guidelines for whom, in the Investigator’s opinion, intravenous (IV)
    or oral antimicrobial therapy is appropriate (IDSA Guidelines, CID
    204;39:885-910).
    Moderate infection severity guideline: Infection in a patient who is
    systemically well and metabolically stable characterized by the
    presence of ≥ 2 manifestations of inflammation (purulence or
    erythema, pain, tenderness, warmth, or induration) that has ≥ 1 of
    the following characteristics: cellulitis extending 2 cm,
    lymphangitic streaking, spread beneath the superficial fascia,
    deep-tissue abscess, gangrene, and involvement of muscle, tendon,
    joint or bone.
    4. Has had an x-ray of the infected area within the 2 days immediately
    preceding or at Visit 1 (Baseline/Randomization) to document the presence or absence of osteomyelitis. Patients with osteomyelitis
    must receive appropriate surgical intervention to remove all necrotic
    and infected bone and otherwise meet enrollment criteria before
    being enrolled in the study.
    5. Meets the following laboratory criteria:
    • Hemoglobin (Hb) > 10 g/dL.
    • White blood cells (WBC) ≥ 4000 cells/mm3 and/or absolute
    neutrophil count (ANC) ≥ 1500 cells/mm3.
    • Alanine aminotransferase (ALT) or aspartate aminotransferase
    (AST) within 3x the upper limit of normal (ULN).
    • Hemoglobin A1C (HbA1C) < 10%.
    6. Has an ankle-brachial index (ABI) ≥ 0.7 and ≤ 1.3. (Note:
    Patients with ABI < 0.7 or > 1.3 may be included if they have
    either a transcutaneous oxygen pressure or a toe
    pressure ≥ 40 mm Hg on limb with ulcer.)
    7. If female, is nonpregnant (negative pregnancy test results at the
    Baseline/Randomization Visit) and nonlactating.
    8. If female, is either not of childbearing potential (defined as
    postmenopausal for ≥ 1 year or surgically sterile [bilateral tubal
    ligation, bilateral oophorectomy or hysterectomy]) or practicing 1 of
    the following medically-acceptable methods of birth control and
    agrees to continue with the regimen throughout the study:
    • Oral, implantable or injectable contraceptives for 3 consecutive
    months before the Baseline/Randomization Visit.
    • Total abstinence from sexual intercourse (≥ 1 complete
    menstrual cycle before the Baseline/Randomization Visit).
    • Intrauterine device (IUD).
    • Double barrier method (condoms, sponge, diaphragm or
    vaginal ring with spermicidal jellies or cream).
    9. Willing to return to the study facility for the Final Study Visit.
    10. Must be able to fluently speak and understand English and be able to
    provide meaningful written informed consent for the study.
    E.4Principal exclusion criteria
    Has a known history of hypersensitivity to gentamicin (or other
    systemic aminoglycosides) or levofloxacin or drugs in the same
    class, or any of the test article or reference product components.
    2. Has a known hypersensitivity to bovine collagen.
    3. Has any uncontrolled illnesses that, in the opinion of the
    Investigator, would interfere with interpreting the results of the
    study.
    4. Has a target ulcer with a wound size > 10 × 10 cm.
    5. Has gangrenous tissue of the affected limb that cannot be removed
    with a single debridement.
    6. Has wound known to contain isolates resistant to levofloxacin.
    7. Has a wound associated with prosthetic material or device.
    8. Received any topical or systemic antimicrobial therapy within the
    2 weeks prior to study entry (Visit 1 [Day 1]).
    9. If severely immunocompromised, may be excluded at the discretion of the Investigator.
    10. Has a history of alcohol or substance abuse in the past 12 months.
    11. Has serum creatinine > 3 mg/dL, is undergoing dialysis (renal or
    peritoneal) or has a history of kidney transplant.
    12. Has a history of myasthenia gravis or other neurological condition
    where gentamicin use is contraindicated as determined by the
    Investigator.
    13. Has a history of epilepsy
    14. Has a history of tendon disorders related to fluoroquinolone
    administration
    E.5 End points
    E.5.1Primary end point(s)
    Percent of patients with a clinical outcome of “clinical cure” in each
    treatment group at Visit 3 (Day 7)

    Clinical cure is defined as: The resolution of all signs and symptoms of infection(purulence or evidence of inflammation) tht were present at enrollment and the patient requires no further antimicrobial therapy or surgical intervention to treat the infection.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 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) Yes
    E.8.2.2Placebo No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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 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 end of th etrial will be at the last visit of the last patient 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 months0
    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 months2
    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 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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 75
    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 Decision2008-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-04-14
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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