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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   38876   clinical trials with a EudraCT protocol, of which   6392   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
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    EudraCT Number:2005-001245-41
    Sponsor's Protocol Code Number:2005/Diaminodiphenylsulfon/1
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-08-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedAustria - BASG
    A.2EudraCT number2005-001245-41
    A.3Full title of the trial
    A single-center, randomized, double-blind, placebo-controlled

    trial evaluating the efficacy and safety of Dapsone in adult

    patients with cutaneous leukocytoclastic vasculitis

    A.3.2Name or abbreviated title of the trial where available
    Placebo-controlled trial evaluating Dapsone for the treatment of leukocytoklastic vasculitis
    A.4.1Sponsor's protocol code number2005/Diaminodiphenylsulfon/1
    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 SponsorDepartment of Dermatology, Hospital of the Medical University Graz
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    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 Information not present in EudraCT
    D. name Dapsone
    D. of the Marketing Authorisation holderFatol
    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.3.1Product nameDapsone/Diaminodiphenylsulfone
    D.3.4Pharmaceutical form Capsule*
    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 INNDapsone
    D.3.9.1CAS number 80-08-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D. medicinal product typeIt works inside the infecting cell to stop the manufacture of a chemical called folinic acid. Through an unknown mechanism dapsone is also effective in treating leukocytoclastic vasculitis
    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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cutaneous leukocytoclastic vasculitis is an inflammatory vascular disease and is manifested clinically by a spectrum of cutaneous lesions, although “papable purpura” is its clinical hallmark. The pathogenetic role of the deposition of immune complexes and complement in the vessel wall and the subsequent recruitment of polymorphonuclear leukocytes that mediate tissue injury have been shown. Dapsone (4,4´- diaminodiphenylsulfone, DDS) may inhibit this pathogenetic mechanism
    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
    Primary Objective
    To determine the efficacy of a one-month administered therapy with dapsone (1,5mg/kg) compared to placebo in subjects with cutaneous leucocytoclastic vasculitis
    E.2.2Secondary objectives of the trial
    ·To determine the efficacy of a two-month administered maintenance therapy with dapsone (1,5mg/kg) compared to placebo in subjects with cutaneous leucocytoclastic vasculitis
    ·To assess the rate of complete response at weeks 4 and 12
    ·To assess the durability of response after maintenance therapy at weeks 16, 24 and 36
    ·To assess the rate of IgA-mediated vasculitis
    ·To determine the efficacy of dapsone in the different subtypes of chronic cutaneous leukocytoclastic vasculitis
    · To assess the safety of dapsone therapy
    · To assess the effects of dapsone on quality of life

    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Inclusion Criteria

    To be eligible for the study, subjects must meet all of the following criteria:

    ·Must be 18 years or older at time of enrolment; may be female or male
    ·Have had a diagnosis of cutaneous leukocytoclastic vasculitis (CLV) at least one month prior to screening
    ·Positive histologic and/or direct immunofluorescence findings
    ·Are candidates for systemic therapy of CLV (previous medication must be discontinued 2 weeks prior to baseline visit).
    ·Women of childbearing potential have to undergo a urine pregnancy test continously and must be using adequate birth control measures (eg. abstinence, oral contraceptives, intrauterine device) during dapsone therapy.
    ·Must be able to adhere to the study visit schedule and other protocol requirements
    ·Must be capable of giving informed consent and the consent must be obtained prior to any study related procedures
    ·Must have screening laboratory test results within the following parameters:

    o Hemoglobin > 10 g/dl
    o Met-Hb < 5% prior to dapsone therapy
    o Leucocytes > 6 G/l
    o Serum Creatinine < 1,5 mg/dl
    o GOT < 50 U/l
    o GPT < 65 U/l
    o Total Bilirubin < 1.5 mg/dl
    o Thrombocytes > 144 G/l

    E.4Principal exclusion criteria
    Exclusion Criteria

    ·Subjects who meet any of following criteria may not be enrolled in the study:
    ·CLV with significant systemic manifestation and/or severe necrotizing and ulzerating cutaneous vasculitis.
    ·Patients with CLV of less than one month´s duration
    ·Have a history of any clinically significant hypersensitivity reaction/adverse reation to sulfonamides
    ·Patients with glucose-6-phosphate dehydrogenase, glutathione reductase or methemoglobin reductase deficieny
    ·Have current signs or symptoms of severe progressive, or uncontrolled renal (Creatinine Clearance<25ml/min, proteinuria, hematuria), hepatic, haematological, gastrointestinal, pulmonary, cardiac, neurologic, cerebral or psychiatric disease
    ·Thyroid dysfunction ( hypothyroidism )
    ·Pregnancy and lactation period
    ·Are participating in another trial using an investigational agent or procedure during participation in this trial

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the study is the proportion of subjects who are marked responders to week 4. (Proportion of subjects achieving a >75% improvement in CLV from baseline at week 4, measured primarily by the number of cutaneous lesions per traget lesion; "target lesion" means an area of 9 cm2, being defined at screening period and showing most cutaneous involvment [number of purpura patches and papules will be ssessed]).
    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 Information not present in EudraCT
    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. 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 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.8.3 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    After 4 weeks the data will be analysed by an independent statistican. The study will be terminated if the proportion of marked responder is below 25%.

    If study treatment is discontinued due to lack of efficacy after 4 weeks, the subject should return for all scheduled evaluations. (see 4.3; study protocol)

    Generally, the trial is finalised, if all included subjects (62) underwent the scheduled visits as described in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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.1.3Elderly (>=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 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 2005-08-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state62
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 62
    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)
    If there is no response of study- treatment , therapy with any of these medications listed below, is possible and include systemic corticosteroids, nonsteroidal anti-inflammatory drugs cholchicine, potassium iodide, antihistamines, fibrinolytic agents, aminocaproic acid immunosuppressive agents (cyclophosphamide, methotrexate, azathioprine and cyclosporine) and monoclonal antibodies , as well as Dapsone (if the patient belonged to the placebo-arm)

    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 Decision2005-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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