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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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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    Summary
    EudraCT Number:2007-005082-34
    Sponsor's Protocol Code Number:A2620383
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-005082-34
    A.3Full title of the trial
    A Proof of Principle Study to Investigate the Efficacy of a
    Medical Device and Topical Analgesic Combination for the
    Treatment of Pain and Performance Related Function in
    Osteoarthritis
    A.3.2Name or abbreviated title of the trial where available
    PoP for Device and Analgesic Combination
    A.4.1Sponsor's protocol code numberA2620383
    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 SponsorGlaxoSmithKline Consumer Healthcare
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name Voltarol Emulgel P
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Consumer Health UK
    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.3.1Product nameVoltarol Emulgel P
    D.3.4Pharmaceutical form Cutaneous emulsion
    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
    D.3.9.1CAS number 78213-16-8
    D.3.9.3Other descriptive nameDiclofenac Diethylamine
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.16
    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 Information not present in EudraCT
    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 placeboCutaneous emulsion
    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
    To compare the efficacy of 72 hours (hrs) treatment of topical diclofenac plus a heat patch with 72 hrs treatment of topical diclofenac plus a placebo patch on the primary endpoint of mobility in presence of OA inflammation.
    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 of this study is to compare the efficacy of 72 hours (hrs) treatment of topical diclofenac plus a heat patch with 72 hrs treatment of topical diclofenac plus a placebo patch on the primary endpoints:
     Time to climb stairs;
     Pain following stair climbing.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to compare the efficacy of 72 hrs treatment of topical diclofenac plus a heat patch with 72 hrs treatment of placebo gel plus a heat patch on:
     Time to climb stairs;
     Pain following stair climbing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age
    Aged at least 50 years.
    2) Diagnosis
    a) Has a radiological diagnosis of OA affecting at least one knee.
    b) Has symptomatic OA of at least one knee. The symptoms should be significantly worse in one knee than the other if OA affects both knees.
    c) When questioned at the screening visit, confirm they experience at least mild pain when climbing stairs.
    d) Able to walk unaided or with the aid of one stick (2 sticks not allowed).
    3) Contraception
    Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception.
    4) Compliance
    Understands and is willing, able and likely to comply with all study procedures and restrictions.
    5) Consent
    Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
    6) General Health
    Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history, physical examination or clinical laboratory test.
    E.4Principal exclusion criteria
    1) Pregnancy
    Women who are pregnant or who have a positive urine pregnancy test.
    2) Breast-feeding
    Women who are breast–feeding.
    3) Medical History
    a) Suffer from any other condition that would affect their ability to rate pain, complete the exercises or refrain from treatment.
    b) Are unable to clearly differentiate between symptoms in the joint under investigation compared to the opposite knee.
    c) Have a history or current evidence of the following secondary causes of OA: septic arthritis, inflammatory joint disease, gout, recurrent episodes of pseudogout, Paget’s disease, articular fracture, ochronosis, acromegaly, haemochromatosis, Wilson’s disease, primary osteochondromatosis, heritable disorders (e.g. hypermobility) or collagen gene mutations.
    d) Have any specific contraindications to the use of heat patches including inability to feel heat (e.g. neuropathies, circulatory problems) or have damaged skin (scratch, burn, sunburn etc.).
    e) Have asthma, urticaria, or acute rhinitis which is precipitated by aspirin or other NSAIDs.
    f) Have any skin conditions (e.g. eczema) that might interfere with the use of the patch for a three day period.
    g) Have had a knee replacement (in the knee to be treated).
    4) Medications
    Patients who have started taking glucosamine supplements within the 6 months prior to the start of the study.
    5) Allergy/Intolerance
    Known or suspected intolerance or hypersensitivity to the study materials, washout medication (or closely related compounds) or any of their stated ingredients.
    6) Clinical Study/Experimental Medication
    a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit at the start of the study.
    b) Previous participation in this study.
    7) Substance abuse
    Recent history (within the last year) of alcohol or other substance abuse.
    8) Personnel
    An employee of the sponsor or the study site or an immediate family member, or resident at the same address as another patient in the study.
    E.5 End points
    E.5.1Primary end point(s)
     Time to climb stairs;
     Pain following stair climbing
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 Yes
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 months1
    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) 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    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 Decision2007-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-06-12
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