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    Summary
    EudraCT Number:2011-004356-20
    Sponsor's Protocol Code Number:DCS-002
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-16
    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 ConcernedSweden - MPA
    A.2EudraCT number2011-004356-20
    A.3Full title of the trial
    A randomised, parallel-group, double-blind, placebo-controlled study of DPK-060 to investigate clinical safety and efficacy in patients with acute external otitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised, parallel-group, double-blind, placebo-controlled study of DPK-060 to investigate clinical safety and efficacy in patients with acute swimmers ear
    A.4.1Sponsor's protocol code numberDCS-002
    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 SponsorPergamum AB
    B.1.3.4CountrySweden
    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 supportPergamum AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPergamum AB
    B.5.2Functional name of contact pointJan Alenfall
    B.5.3 Address:
    B.5.3.1Street AddressBanvaktsvägen 12
    B.5.3.2Town/ citySolna
    B.5.3.3Post code171 48
    B.5.3.4CountrySweden
    B.5.4Telephone number464619 21 97
    B.5.5Fax number4646123536
    B.5.6E-mailjan.alenfall@pergamum.com
    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 nameDPK-060
    D.3.2Product code DPK-060
    D.3.4Pharmaceutical form Ear drops, 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.3.9.2Current sponsor codeDPK-060
    D.3.9.3Other descriptive nameDPK-060
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboEar drops, 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
    Acute external otitis (EO)
    E.1.1.1Medical condition in easily understood language
    Swimmers ear
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK 060 ear drops in patients with acute EO.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate clinical cure and microbiological growth following treatment with DPK 060 2% ear drops compared to placebo for DPK 060 ear drops.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patients have to meet all of the following criteria to be eligible to enter the study:
    1) Signed written informed consent prior to performing any study-related procedures.
    2) A clinical diagnosis of acute EO based on clinical observation and a degree of disease severity normally treated by primary care (and not inducing referral to specialist care).
    3) Age ≥12 years.
    4) Female patients who have been post-menopausal for more than one year.
    Female patients ≤17 years of childbearing potential must agree to avoid pregnancy during the study period. If deemed necessary by the Investigator, they must also have a negative urine pregnancy test and agree to use adequate acceptable contraceptive measures (e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, vasectomised partner or combined birth control pills), during the study period.
    Female patients ≥18 years of childbearing potential must have a negative urine pregnancy test and, if sexually active, agree to use adequate acceptable contraceptive measures (e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, vasectomised partner or combined birth control pills), as judged by the Investigator, during the study period.


    E.4Principal exclusion criteria
    Patients meeting any of the following criteria will not be permitted to enter the study:
    1) Known or suspected allergy or sensitivity to any of the IPs or excipients.
    2) Known or suspected perforation of the tympanic membrane.
    3) A clinical diagnosis of chronic suppurative otitis media,
    acute otitis media, acute otorrhea or malignant otitis externa.
    4) Local ear canal abnormalities such as abscess, granulation or polyps.
    5) Congenital abnormalities of the EAC or obstructive bony exostosis.
    6) Mastoiditis or suppurative non-infectious ear disorders (e.g. cholesteatoma).
    7) Malignant tumour of the EAC.
    8) History of otologic surgery (except for surgery confined to the temporomandibular joint).
    9) Seborrheic dermatitis or other dermatological conditions of the EAC that would complicate evaluation.
    10) Current or prior use (within 7 days) of ear washes using alcohol, vinegar or other astringents.
    11) Any clinically relevant past or present infectious/viral disease, including hepatitis B or C and HIV, which in the opinion of the Investigator may put the patient at risk because of participation in the study, or may influence the results of the study.
    12) Current infection requiring systemic antimicrobial therapy.
    13) Current or prior use of systemic (within 14 days) or topical (within 7 days) antibiotics.
    14) Current or prior use of systemic (within 30 days) or topical (within 7 days) steroids.
    15) History of immune dysfunction/deficiency and immunosuppressive therapy.
    16) Diabetes mellitus.
    17) Any other clinically relevant past or present disease or disorder e.g. cardiovascular, pulmonary, gastrointerstinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment, which in the opinion of the Investigator may put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.
    18) Any clinically relevant abnormal findings in physical examination or vital signs, which in the opinion of the Investigator may put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.
    19) Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
    20) Previous randomisation to treatment in the present study.
    21) Excessive alcohol consumption or known drug abuse.
    22) Scheduled in patient surgery or hospitalisation during the course of the study.
    23) Female patients: currently pregnant or breast-feeding or intending to become pregnant within 1 month after last dose of IP.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK 060 ear drops in patients with acute EO.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated after 7 or 10 days of treatment (as applicable), and at 4 weeks after the last dose of IP.
    E.5.2Secondary end point(s)
    The secondary objectives are to evaluate clinical cure and microbiological growth following treatment with DPK 060 2% ear drops compared to placebo for DPK 060 ear drops.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be assessed as follows:
    1) Clinical cure at Day 8 and Day 11
    2) Microbiological growth (bacteria) at Day 8 and Day 11 compared to baseline (Day 1)
    3) Microbiological growth (fungi) at Day 8 and Day 11 compared to baseline (Day 1)
    4) Ear pain on Day 8 and Day 11 compared to baseline (Day 1)
    5) Use of rescue medication during the treatment period
    6) Relapse rate within 4 weeks after last dose
    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) 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 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.8.2.4Number of treatment arms in the trial2
    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 concerned7
    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
    The end of study is defined as the date of the last patient’s telephone follow-up, or the last patient’s last visit in case the last patient discontinues the study prematurely.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 Yes
    F.1.1Number of subjects for this age range: 30
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state69
    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)
    Expected normal treatment for the condition comes after the last phone follow-up.
    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 Decision2011-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-02
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