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    Summary
    EudraCT Number:2007-004331-27
    Sponsor's Protocol Code Number:P05205
    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:2008-09-23
    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 number2007-004331-27
    A.3Full title of the trial
    A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of SCH 900340 5% Solution Compared with Vehicle Administered Topically in the Treatment of Distal Subungual Onychomycosis of the Toenail.

    NOTE: "The product to be used in the clinical trial is a "Topical Solution". Of the choices provided in Section D.3.4 Pharmaceutical Form; per the standard list, "Medicated Nail Lacquer" was selected at this time."
    A.4.1Sponsor's protocol code numberP05205
    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 SponsorSchering-Plough Research Institute, a Division of Schering Corporation
    B.1.3.4CountryUnited States
    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 nameSCH 900340 Topical Solution, 5% w/w
    D.3.2Product code SCH 900340
    D.3.4Pharmaceutical form Medicated nail lacquer
    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 INNSCH 900340
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboMedicated nail lacquer
    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
    Onychomycosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10030338
    E.1.2Term Onychomycosis
    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 of the study is to evaluate the efficacy of SCH 900340 5% solution relative to its vehicle in the treatment of onychomycosis of the toenail, as determined by various efficacy measurements.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are: To assess the safety and tolerability of SCH 900340 5% solution; and, To explore patient-reported outcomes of SCH 900340 5% solution.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be 18 to 75 years of age (both inclusive) at Screening, and can be of either sex and of any race.
    2. Subjects must have distal subungual onychomycosis due to dermatophytes that:
    (a) involves at least 25% of the total area (ie, the area circumscribed by the distal groove and the proximal and lateral nail folds) of the target great toenail according to the investigator's visual inspection after properly trimming the nail
    (b) does not involve the proximal 25% of the nail (no nail matrix involvement)
    (c) has been mycologically confirmed at Screening (central laboratory KOH and central laboratory culture positive for dermatophytes).
    3. Subjects must have the target great toenail capable of growing, as assessed by the investigator during Screening.
    4. Subjects must have a thickness of the distal target great toenail plate of ≤3 mm as measured at Screening by the investigator or a subinvestigator.
    5. Subjects must be able to apply the study drug to their toenails.
    6. Subjects must agree to use no other products (including nail polish) applied to the toenails during the study.
    7. Subjects' clinical laboratory tests (hematology and blood chemistries) must be clinically acceptable to the investigator.
    8. Women of child-bearing potential who are currently sexually active must agree to use a medically accepted method of contraception prior to randomization, while receiving protocol-specified medication, and for 4 weeks after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation).
    9. Women of child-bearing potential who are not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.
    E.4Principal exclusion criteria
    1. Subjects with anatomic abnormalities of the target great toenail, including but not limited to genetic nail disorders, pigmentary disorders, onychogryposis, trauma to the nail, and/or any other abnormalities that in the investigator's judgment may interfere with efficacy assessments.
    2. Subjects with one or more of the following conditions on the target great toenail:
    a. proximal subungual onychomycosis,
    b. white superficial onychomycosis, dermatophytoma, exclusively lateral disease, or yellow/brown spikes,
    c. any non-dermatophyte infection (eg, Scopulariopsis spp and Scytialidium spp),
    d. any other condition (eg, past history of trauma) that in the opinion of the Investigator could interfere with the ability of the investigator to assess the subject's response to the study medication.
    3. Subjects with a current or past history of psoriasis and/or lichen planus.
    4. Subjects with clinically significant nonfasting serum glucose levels at Screening will have a repeat fasting test including glucose and hemoglobin A1C (Hgb A1C) during the Screening phase. Subjects with Hgb A1C ≥8% will be excluded from the study.
    5. Subjects with significant peripheral vascular disease or peripheral circulatory impairment, as evidenced by absence of dorsalis pedis or posterior tibial pulses.
    6. Subjects with chronic tinea pedis (eg, moccasin type) that in the investigator's judgment would require systemic therapy.
    7. Subjects with a history of chronic mucocutaneous candidiasis.
    8. Subjects with a history of any known immunodeficiency.
    9. Subjects with a history of treatment failure (defined as no recognized increase in clear nail growth) after completion of >=3 months of any oral antifungal administered according to label.
    10. Subjects who have received treatment for any type of cancer within the last 6 months, except non melanoma skin cancer.
    11. Subjects who have received any treatment listed below more recently than the indicated washout period or who must continue to receive such treatments:
    Prohibited Medications (Washout Period)
    -Systemic antifungal treatments (24 weeks prior to Screening),
    -Topical antifungal agents applied to the toenails, excluding antifungal agents for the treatment of tinea pedis (12 weeks prior to Screening),
    -Oral or intramuscular corticosteroid and oral or intramuscular immunosuppressive agents (4 weeks prior to Screening),
    -Topical anti-inflammatory, topical corticosteroid, and topical immunosuppressive agents applied to the feet (2 weeks prior to Day 1),
    -Investigational drugs (4 weeks prior to Screening),
    -Topical antifungal agents for the treatment of tinea pedis (1 week prior to Screening).
    12. Subjects with a history of street drug or alcohol abuse within 6 months prior to Screening, as determined by the investigator.
    13. Women who are breast-feeding, pregnant, or intend to become pregnant.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is related to the primary objective of the study. The primary efficacy endpoint of the study is the complete cure rate of the target great toenail at Week 48.
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    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 months19
    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 months19
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-09-23. Yes
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 369
    F.4.2.2In the whole clinical trial 600
    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 Decision2008-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
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