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    Summary
    EudraCT Number:2011-003402-25
    Sponsor's Protocol Code Number:OCT-UKE-2011
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-08-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-003402-25
    A.3Full title of the trial
    Randomized, Double-blind, Single-center, Placebo-controlled Study to evaluate the Efficacy of octenisept® in Patients with Chronic Wounds.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Monozentrische, randomisierte, placebo-kontrollierte, doppelblinde Studie zur Untersuchung der Wirksamkeit von octenisept® bei Patienten mit chronischen Wunden.
    A.4.1Sponsor's protocol code numberOCT-UKE-2011
    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 SponsorSchülke & Mayr 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 supportSchülke & Mayr GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Center North, MediGate GmbH
    B.5.2Functional name of contact pointClinical Trial Informations
    B.5.3 Address:
    B.5.3.1Street AddressMartinistr. 52, Building W14
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number+4940741051627
    B.5.5Fax number+4940741051624
    B.5.6E-mails.borregaard@uke.de
    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.2.1.1.1Trade name octenisept®
    D.2.1.1.2Name of the Marketing Authorisation holderSchülke & Mayr GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    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 INNOCTENIDINE DIHYDROCHLORIDE
    D.3.9.1CAS number 70775-75-6
    D.3.9.4EV Substance CodeSUB03484MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN2-PHENOXYETHANOL
    D.3.9.1CAS number 122-99-6
    D.3.9.4EV Substance CodeSUB16187MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 No
    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 placeboCutaneous solution
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic leg ulcers
    E.1.1.1Medical condition in easily understood language
    Chronic wounds
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068310
    E.1.2Term Leg ulcer
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy of octenisept® compared to NaCl solution and antimicrobial effect in chronic wounds. Decrease of bacterial load after 14 days of treatment will be used as a parameter for efficacy. Bacterial count will be defined with a semi-quantitative bacterial swab.
    E.2.2Secondary objectives of the trial
    - To assess subjective tolerance of octenisept® using the PBI and FLQA questionnaire
    - To evaluate the wound healing time and wound size
    - Development of bacterial load at the follow-up visit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients of at least 18 years at the time of consent
    - Females of non-childbearing potential (postmenopausal ≥ 50 years old and amenorrhea ≥ 12 month after break of exoge-nous hormones or ≤ 50 years old, documented FSH – and LH level equal to the postmenopausal range and amenor-rhea ≥ 12 after break of all exogenous hormones)
    - Females of non-childbearing potential due to postoperative bilateral tubal ligation, bilateral salpingectomy, bilateral oo-phorectomile or hysterectomy
    - Patients with a venous leg ulcer (Ulcus cruris)
    - Patients with a chronic leg ulcer
    - Duration of the target venous ulcer ≥ 4 weeks
    - Surface area of the target venous ulcer (after debridement) ≥ 1
    - Patients with a chronic leg ulcer with bacterial load suspected in at least one of the following bacterial species:
    o Staphylococcus aureus
    o Streptococcus pyogenes
    o Enterococcus spp.
    o Escherichia coli
    o Proteus mirabilis
    o Pseudomonas aeruginosa
    - Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, clinical [vital signs, 12-lead electro-cardiogram (ECG)], and clinical laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the In-vestigator
    - Ability to provide written informed consent
    - Signed declaration of consent
    - Willingness to cooperate
    E.4Principal exclusion criteria
    - Females of childbearing potential
    - Known history of alcohol or drug abuse
    - Patients with a serious concomitant disease (serious coronary heart disease, serious heart failure (NYHA III or IV), serious nephrotic - or hepatic dysfunction, malign disease, dementia) will be excluded if the investigator decides that study inclusion is not recommended.
    - Known history of allergic reactions attributed to octenisept® or one of its compounds
    - Participation in another clinical trial within the last 30 days before randomization
    - Contraindication regarding local wound therapy with local antimicrobial agents (e.g. inflamma-tion requiring systemic antibiotic therapy, malignant ulcer)
    - Planned ulcer treatment within the treatment period after Visit 1 e.g. surgery on varicose veins (laser coagulation, sclerotherapy, stripping), skin grafting, application of cultured keratino-cytes, bioengineered tissue, biophysical modalities
    - Not permitted therapy within the last 7 days prior to the first dose:
    • use of any systemic antibiotics
    • local antimicrobial agents and topical steroid treatment of the target ulcer (these drugs confound the efficacy of the investigational drug)
    - Concomitant treatment with other preparations that interfere with the trial preparation or the disease
    - Absence of declaration of consent
    - Doubt about willingness to cooperate
    - Non-fulfillment of the inclusion criteria
    - Staff of the study centre, the investigator him/herself or close relatives of the investigators
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of the log sum of standardized bacterial densities of 6 bacteria species after 1 and 2 weeks in comparison to baseline determined directly before start of treatment
    - Staphylococcus aureus
    - Streptococcus pyogenes
    - Enterococcus spp.
    - Pseudomonas aeruginosa
    - Escherichia coli
    - Proteus mirabilis
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 1 and 2 weeks in comparison to baseline ( determined directly before start of treatment)
    E.5.2Secondary end point(s)
    - Wound size after 2 weeks of treatment
    - Patient benefit determined with the PBI and FLQA question-naire after 2 weeks of treatment
    - Descriptive analysis: occurrence of multi-resistant strains
    - Safety: IMP related Adverse Events
    E.5.2.1Timepoint(s) of evaluation of this end point
    see above
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LPLV
    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 months4
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 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 state70
    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)
    Die teilnehmenden Patienten werden aus dem Patientenpool des Principal Investigators rekrutiert und befinden sich regulär in medizinische Betreuung in dem Zentrum und werden auch nach Abschluss der klinischen Pürfung, bzw. nach dem Ausscheiden aus der klinischen Prüfung adäquat medizinisch versorgt.
    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 Decision2011-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-06-19
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