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    Summary
    EudraCT Number:2012-004024-38
    Sponsor's Protocol Code Number:194-P-308
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-25
    Trial results Removed from public view
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-004024-38
    A.3Full title of the trial
    A 4-week, randomized, double-blind, multi-center, vehicle-controlled, parallel group study to assess the efficacy and safety of diclofenac diethylamine 2.32% gel for the relief of signs and symptoms in patients with knee osteoarthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to evaluate the efficacy and safety of diclofenac diethylamine 2.32% gel in subjects with knee osteoarthritis
    A.4.1Sponsor's protocol code number194-P-308
    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 SponsorNovartis Consumer Health S.A.
    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 supportNovartis Consumer Health SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Consumer Health SA
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressRoute de l'Etraz
    B.5.3.2Town/ cityNyon
    B.5.3.3Post code1260
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41226365158
    B.5.5Fax number+41223633007
    B.5.6E-mailChristian-milliet@novartis.com
    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 Voltadol Forte Schmerzgel
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Consumer Health Care - Gebro GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 diethylamine 2.32 Gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    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 INNDiclofenac diethylamine
    D.3.9.1CAS number 78213-16-8
    D.3.9.3Other descriptive nameVoltaren 2.32% gel
    D.3.9.4EV Substance CodeSUB01669MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.32
    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 placeboGel
    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
    Knee osteoarthritis
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis of the knee
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    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 DDEA 2.32% gel b.i.d. vs. vehicle on POM after 2 weeks of treatment in patients suffering from knee OA.
    E.2.2Secondary objectives of the trial
    To study the onset and the durability of the effect of the study medication in the target knee and its effect in the contralateral knee over 4 weeks;
    To determine persistence of the effect of the study medication over 12 hours when applied twice daily;
    To determine the effect of the study medication on Night Pain and Morning Stiffness when applied in the evening;
    To determine the treatment effect using a standardized model of Induced Pain (10 min Walk Test);
    To evaluate the safety of the regimen by physical examination, ECG, and clinical laboratory before and after treatment, and by monitoring vital signs, local tolerability, and AEs throughout the treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must give written informed consent before any assessment is performed.
    At screening visit
    2. Male or female ≥ 50 years old;
    3. Symptomatic OA of one or both knees, according to American College of Rheumatology (ACR) criteria, diagnosed at least 6 months previously;
    4. Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA;
    5. Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit;
    6. Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1 2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study;
    7. If female of childbearing potential (not postmenopausal for>1 year or surgically sterilized), agree to maintain an effective method of contraception throughout the study.
    At baseline visit
    8. Negative pregnancy test if female of child-bearing potential;
    9. POM in one knee (which is designated as the target knee) higher by ≥ 25 mm vs. the other knee;
    10. POM in the target knee increased by ≥ 10 mm vs. screening visit;
    11. POM ≥ 50 mm in the target knee;
    12. Pain was predominant in the target knee during the entire screening period and for 6 months preceding the screening visit;
    13. Radiograph of the target knee, no more than one year old, showing evidence of OA, Kellgren-Lawrence grade 1-3;
    14. No current hip or back pain
    E.4Principal exclusion criteria
    General
    1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
    2.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
    3. Long QT syndrome or QTc>450 ms for males and >470 ms for females at screening or baseline
    4.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastases
    5.Pregnant or nursing women
    6.If a female of childbearing potential (i.e. not>1 year postmenopausal or surgically sterilized), agree to maintain an effective method of contraception throughout the study.
    Particular exclusion criteria
    7.Partial or total replacement of either knee joint, past or planned/expected during study
    8.OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (common risk factors, such as obesity and past meniscectomy or ligament rupture and repair are allowed)
    9.History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis) or laboratory values indicative of such disease with subsequent diagnosis by a physician
    10.Fibromyalgia within the previous year
    11.Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs, or any of the ingredients in the gel (isopropyl alcohol, propylene glycol or butylhydroxytoluene) or any other contraindication for study drug or rescue medication
    12.Skin lesions or wounds in the affected area
    13.Evidence of active peptic ulceration within the previous year or history of gastrointestinal bleeds
    14.Clinically significant medical disease, which would compromise the subject’s welfare or confound the study results, such as severe/uncontrolled renal, hepatic, hematological, endocrine, cardiovascular, and neurological diseases within the previous year
    15.Use of any of the following treatments prior to the screening visit or between screening and baseline visit:
    i)any topical analgesic or anti-inflammatory treatment on either knee within the previous month,
    ii)any intra-articular or peri-articular procedures or injections in either knee within the previous 3 months,
    iii)any systemic treatment with corticosteroids within the previous 6 weeks (topical treatments with corticosteroids not related to either knee are permitted),
    iv)any chondroprotectant or disease-modifying OA drugs, such as glucosamine or chondroitin sulfate, unless dose was stable over the previous month and will be maintained throughout the study,
    v)opiates, muscle relaxants or tranquilizers within the previous month except stable low doses of antidepressants, anxiolytics, and sleeping aids taken at bedtime, present at the screening visit and maintained throughout the study,
    vi) any systemic anti-inflammatory or analgesic drugs at screening if 5 times their elimination half-time exceeds 7 days (i.e., if half-life >33.6 h),
    vii) anticoagulants such as warfarin or heparin in the preceding week or antiaggregants within the previous month other than aspirin at stable low doses started at least one month before randomization and kept at a constant dose throughout the study,
    viii) any other investigational drugs within the previous month;
    16. Any of the following prior to the baseline visit:
    i) not washed out systemic anti-inflammatory or analgesic drugs except rescue medication for at least 7 days (aspirin at stable low dose for cardiovascular prevention is allowed if started at least one month before randomization),
    ii) not discontinued rescue medication use for at least 24 hours;
    17.Any of the following during the wash-out period or the treatment period:
    i) subject is unwilling to avoid the use of any topical or systemic analgesic or anti-inflammatory treatments other than the study medication and the rescue medication,
    ii) subject expects to require systemic steroids or any intra- or periarticular procedures or injections in either knee,
    iii) physical or acupuncture therapy,
    iv) initiation of a new exercise regime or increase in the rigor of the current exercise regimen;
    18.Significant injury to either knee within six months prior to screening;
    19.Major knee surgery of either knee within one year prior to screening;
    20.Evidence of liver disease or significant increase of hepatic enzymes or evidence of drug or alcohol abuse;
    21.Any physical impairment that would influence the study’s efficacy evaluations, such as peripheral or central neurological disease, or any painful condition of the lower extremities other than knee OA (e.g.painful nail, wound, corn, or wart);
    22.Any cognitive impairment that would, in the investigator’s opinion, preclude study participation or compliance with study procedures (e.g., Alzheimer’s dementia).
    23.Vulnerable individual
    E.5 End points
    E.5.1Primary end point(s)
    Outcome of POM, assessed on a 100-mm visual analogue scale
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 2 weeks treatment.
    E.5.2Secondary end point(s)
    • POM at visits other than Visit 4;
    • POM in the contralateral knee at all post-baseline visits;
    • WOMAC Pain, Function and Stiffness subscales at all post-baseline visits;
    • Induced Pain (Walk Test) at all post-baseline visits;
    • SF-12 (Short Form-12 Health Survey).
    E.5.2.1Timepoint(s) of evaluation of this end point
    • POM at visits other than Visit 4;
    • POM in the contralateral knee at all post-baseline visits;
    • WOMAC Pain, Function and Stiffness subscales at all post-baseline visits;
    • Induced Pain (Walk Test) at all post-baseline visits;
    • SF-12 (Short Form-12 Health Survey) at all visits.

    •
    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) Yes
    E.8.2.2Placebo Yes
    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 concerned16
    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
    Last subject last visit.
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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 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: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 126
    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 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 state252
    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)
    After the end of the study the patients will go back to their previous treatments.
    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 Decision2013-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-05
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