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    Summary
    EudraCT Number:2009-015090-12
    Sponsor's Protocol Code Number:04082009
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2009-015090-12
    A.3Full title of the trial
    Standard Treatment Or topical doxepin against Pruritus
    in burn patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Standard Treatment Or topical doxepin against Pruritus
    in burn patients
    A.3.2Name or abbreviated title of the trial where available
    STOP trial
    A.4.1Sponsor's protocol code number04082009
    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 SponsorAssociation of Dutch Burn Centres
    B.1.3.4CountryNetherlands
    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 supportAssociation of Dutch Burn Centres
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssociation of Dutch Burn Centres, Martini Hospital
    B.5.2Functional name of contact pointPrincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressVan Swietenplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9728 NT
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310505245565
    B.5.6E-mailH.C.Kuipers@mzh.nl
    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 Yes
    D.2.1.1.1Trade name Xepin
    D.2.1.1.2Name of the Marketing Authorisation holderCambridge Healthcaree Supplies 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.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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.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 Tavegyl
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Consumer Health B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCream
    D.8.4Route of administration of the placeboCutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Pruritus in patients with burns
    E.1.1.1Medical condition in easily understood language
    Itch in patients with burns
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10006799
    E.1.2Term Burns NOS
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10037090
    E.1.2Term Pruritus cutaneous
    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
    To evaluate whether doxepin hydrochloride 5% cream is more effective in reducing pruritus in patients with burns than standard treatment.
    E.2.2Secondary objectives of the trial
    To evaluate whether patients treated with doxepin hydrochloride 5% cream compared to standard treatment:
    - have a better quality of life
    - have less erythematous scars
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with healed burns and itch. Patients are divided into four groups i.e.
    1) patients with partial thickness wounds, not exceeding 4 months postburn
    2) patients with full thickness wounds, not exceeding 4 months postburn
    3) patients with partial thickness wounds between 4 months postburn and 3 years postburn
    4) patients with full thickness wounds between 4 months postburn and 3 years postburn
    • Itch intensity as assessed by VAS score greater than or equal to 3
    • Patients treated in one of the three Dutch burn centres
    • Patients aged 18 years or older
    E.4Principal exclusion criteria
    - Inability to give informed consent by patient or legal representatives
    - Inability to understand and fill in VAS scores and quality of life/pruritus assessment questionnaires, as judged by the treating physician
    - (Active) cutaneous or systemic disease causing itch
    - Any disease or condition which, according to the physician's judgement, is associated with adverse effects using doxepin, that is:
    Contra-indications Tavegil
    - hypersensitivity to clemastine or other arylalkylamine antihistamines, or any of the excipients
    - porphyria
    Precautions Tavegil:
    - fructose intolerance
    - narrow-angle glaucoma
    - stenosing peptic ulcer
    - pyloroduodenal obstruction
    - prostatic hypertrophy with urinary retention and bladder neck obstruction
    - galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
    - pregnancy and lactation
    Contra-indications Xepin:
    - hypersensitivity to any of its components.
    Precautions Xepin
    - glaucoma
    - a tendency to urinary retention
    - severe liver disease
    - mania
    - severe heart disease (including cardiac arrythmias)
    - pregnancy and lactation
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameters are change in mean pruritus intensity; VAS scores from baseline during 12 weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    VAS pruritus: 0 weeks (inclusion), day 1-13 (daily), 2 weeks, 6 weeks, 12 weeks (end of study)
    E.5.2Secondary end point(s)
    Secondary study parameters include quality of life as measured by the SF-36 questionnaire, characteristics of the itch as measured by the Burn Itch Questionnaire, reported somnolence and response of erythema.
    Other study parameters include use of escape moisturizer and use of pressure garments. Furthermore age, gender, location of burn wound, post-burn period, total body surface area, size of itching area, length of period of itch, treatment before inclusion (if applicable) will be recorded.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - SF-36 questionnaire: 0 weeks (inclusion), 12 weeks (end of study)
    - Burn Itch Questionnaire: 0 weeks (inclusion), 12 weeks (end of study)
    - somnolence: 0 weeks (inclusion), day 1-13 (daily), 2 weeks, 6 weeks, 12 weeks (end of study)
    - erythema: 0 weeks (inclusion), 2 weeks, 6 weeks, 12 weeks (end of study)
    - use of escape moisturizer: 0 weeks (inclusion), day 1-13 (daily), 2 weeks, 6 weeks, 12 weeks (end of study)
    - use of pressure garments: 0 weeks (inclusion), day 1-13 (daily), 2 weeks, 6 weeks, 12 weeks (end of study)
    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 No
    E.6.5Efficacy No
    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) Yes
    E.8.2.2Placebo No
    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 concerned3
    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
    LVLS
    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 months
    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: 103
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 2013-07-23. 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 state108
    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)
    When the participation in the trial has ended, patients will be treated according to the standard protocol.
    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 Decision2013-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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