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    Summary
    EudraCT Number:2006-004524-36
    Sponsor's Protocol Code Number:FESB-DE-310
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-004524-36
    A.3Full title of the trial
    A randomized, double-blind, vehicle controlled, single center, intra-individual comparative study of the efficacy and safety of diclofenac sodium 1 mg/g (0.1%) gel in subjects with painful UV-induced erythema
    A.3.2Name or abbreviated title of the trial where available
    Diclofenac sodium 1 mg/g (0.1%) gel
    A.4.1Sponsor's protocol code numberFESB-DE-310
    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 SponsorNovartis Consumer Health SA
    B.1.3.4CountrySwitzerland
    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 namediclofenac sodium 1mg/g (0.1%) gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdiclofenac sodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relief of pain and erythema associated with superficial sunburn
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10042496
    E.1.2Term Sunburn
    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 this trial is to compare the efficacy of Diclofenac sodium 1 mg/g (0.1%) gel to vehicle in relieving provoked pain (tactile stimulus by gloved finger) associated with sunburn in the first 24 hours after UV irradiation.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to:
    - compare the efficacy of Diclofenac sodium 1 mg/g (0.1%) gel to vehicle in relieving the spontaneous pain associated with sunburn in the first 24 hours after UV irradiation;
    - compare the efficacy of Diclofenac sodium 1 mg/g (0.1%) gel to vehicle in relieving the provoked pain with monofilament (monofilament Hoechst) in the first 24 hours after UV irradiation;
    - compare the efficacy of Diclofenac sodium 1mg/g (0.1%) gel to vehicle in reducing the erythema associated with sunburn in the first 24 hours after UV irradiation;
    - evaluate the safety (local and general) of Diclofenac sodium 1 mg/g (0.1%) gel.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects to be included in this trial must:
    - Sign the written informed consent form prior to the enrolment in the trial;
    - Be in good health, with no abnormal findings in their medical history or on physical examination;
    - Be aged 18 to 55 years;
    - Be a male or non-pregnant, non-lactating female. Women of child-bearing potential have to use acceptable methods of contraception which are surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) and sterilized partners by vasectomy or other means. Total abstinence may be considered as acceptable at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study. Women, of non childbearing potential have to meet the following definition of post-menopausal status: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy.
    - If female, have a negative urine pregnancy test prior to inclusion;
    - Be covered by the French Social Security system (in agreement with the French legislation: Huriet law n° 88.1138 – 20.12.1988);
    - Have no dermatologic disorder which could interfere with the study results or increase the risk of adverse events;
    - Have no skin type providing a skin pigmentation which will not allow discernment of erythema;
    - Have non tanned skin on the areas to be exposed (back);
    - Have a phototype II to III (Fitzpatrick’s classification);
    - Have a normal tolerance to UV and sun.
    E.4Principal exclusion criteria
    Subjects to be excluded are those:
    - Who, if female, is pregnant, planning pregnancy or lactating;
    - With a known hypersensitivity to diclofenac, aspirin, ibuprofen or other NSAIDs;
    - Who have used oral or percutaneous therapy during the month preceding the trial, which may interfere with the results of the trial (e.g. corticosteroids, anti-histamines, NSAIDs, any photo-protecting agents or photo-sensitising drugs etc.);
    - Who received any drug (including any OTC medication) during the week preceding the trial;
    - Suffering from cutaneous diseases such as psoriasis or active atopic dermatitis, even in sites separated from experimental areas;
    - Who are prone to photodermatoses or subject with previous occurrence of photoallergy;
    - Who are immunosuppressed (acquired, congenital or therapeutic);
    - Suffering from any acute or chronic systemic disease or disorder;
    - Involved in any investigational protocol within 3 months prior to the trial;
    - With evidence or history of drug or alcohol abuse;
    - Who are in the exclusion period in the”Fichier National des Volontaires” of the French Ministry of Health;
    - Who is a member or relative of the trial site staff or an employee of the trial site or Sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Provoked pain intensity (tactile stimulus by gloved finger) assessed by the subject on a VAS (0-100 mm) over 24hours. The lower limit (0) indicates no pain and the upper limit (100) indicates severe pain.
    Tactile pain will be recorded immediately prioir to gel application and at 9 time points after gel apllication. The AUC (0-24) of the change in score from baseline will be calculated for each subject for both the active and its vehicle.
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    intra-individual comparison
    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 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 years
    E.8.9.1In the Member State concerned months3
    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 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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state45
    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 Decision2006-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-18
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