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    Summary
    EudraCT Number:2006-006298-26
    Sponsor's Protocol Code Number:CL-033-III-03
    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:2008-01-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-006298-26
    A.3Full title of the trial
    Multicenter, randomized, double-blind, placebo- and active-controlled study of safety and efficacy of two dosages of epicutaneously applied Diractin® (ketoprofen in Transfersome® gel) for the treatment of osteoarthritis of the knee
    A.3.2Name or abbreviated title of the trial where available
    Safety and efficacy of two dosages of Diractin in OA
    A.4.1Sponsor's protocol code numberCL-033-III-03
    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 SponsorIDEA AG
    B.1.3.4CountryGermany
    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 nameDiractin®
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNKetoprofen
    D.3.9.1CAS number 22071-15-4
    D.3.9.2Current sponsor code033/23
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number22,9
    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.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 Celebrex®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer, Switzerland
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameCelecoxib
    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 INNCelecoxib
    D.3.9.1CAS number 169590-42-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboTopical use (Noncurrent)
    D.8 Placebo: 2
    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
    Treatment of osteoarthritis of the knee
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    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 the efficacy of two dosages of Diractin® (50 mg, 100 mg ketoprofen in Transfersome® gel) in patients with mild to moderate pain related to osteoarthritis (OA) of the knee.
    E.2.2Secondary objectives of the trial
    To evaluate the overall safety of two dosages of Diractin® (50 mg, 100 mg ketoprofen in Transfersome® gel) in patients with mild to moderate pain related to OA of the knee.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All of the following criteria have to be met to include a patient in the study:

    • Informed consent signed and dated
    • Age older than 45 years (if age of 18-45, radiological confirmation of
    diagnosis of knee OA is required)
    • Subject has a primary diagnosis of Functional Class I-III OA of the knee
    and subject meets American College of Rheumatology (ACR) clinical

    classification criteria for osteoarthritis of the knee, defined by the following:

    Knee pain and at least 4 of the following 6:
    o Age >50
    o Morning stiffness <30 minutes
    o Crepitus on active motion
    o Bony tenderness
    o Bony enlargement
    o No palpable warmth of synovium
    • Patient able to identify a predominantly painful (index) knee
    • Mild to moderate pain defined by pain on walking on a flat surface of the
    index knee defined by question 1 of the WOMAC rated ≥ 4 and a total
    average WOMAC pain subscale of < 7 at B1 and B2
    • If female, subject is either not of childbearing potential (defined as
    postmenopausal for at least one year or surgically sterile [bilateral tubal
    ligation, bilateral oophorectomy or hysterectomy]) or subject is of
    childbearing potential and practicing one of the following methods of birth
    control:
    o total abstinence from sexual intercourse (minimum one complete
    menstrual cycle before study entry),
    o a vasectomized partner,
    o contraceptives (oral, parenteral, or transdermal) for three consecutive
    months prior to investigational product administration,
    o intrauterine device (IUD), or
    o double-barrier method (condoms, sponge, diaphragm or vaginal ring
    with jellies or cream).

    • If female of childbearing potential, subject has a negative urine pregnancy
    test at screening and B2.
    E.4Principal exclusion criteria
    • Difference in WOMAC pain rating for question 1 or the total average pain
    score between B1 and B2 > 2
    • Skin lesions or dermatological diseases in the treatment area
    • Extreme obesity (BMI > 37)
    • Directly or indirectly involved in the conduct and administration of this
    study (i.e. principal investigator, sub-investigator, study co-ordinators,
    other study staff, employees of IDEA AG, IDEA contractors and/or their
    families)
    • Received any investigational medicinal product within 30 days prior to
    Screening Visit or participation in any previous clinical study with Diractin®
    • Pregnancy or lactation
    • Residents of psychiatric wards, prisons or other state institutions

    • Malignancy within the past 2 years
    • Morbus Meulengracht/Gilbert syndrome
    • Depressive Disorders requiring treatment with tricyclics, treatment with
    other antidepressants must be stable for 3 months prior to screening and
    throughout the study
    • Epilepsy
    • Schizophrenia
    • Neuropathic pain and any other pain condition requiring chronic use of
    pain medication
    • Known hypersensitivity or allergy (including photoallergy) to NSAID´s
    including ketoprofen, celecoxib, sulfonamides, omeprazole, paracetamol
    and to ingredients of the IMP including galactose
    • Preexisting asthma bronchiale or bronchospasm after taking aspirin or
    other NSAIDs
    • Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis,
    gout of the index knee, pseudogout, systemic lupus erythematodes, or
    mixed connective tissue disease
    • Symptomatic ipsilateral hip OA or predominant retropatellar knee OA
    • Coagulopathy or bleeding diathesis, or concomitant use of anticoagulants
    including low dose aspirin
    • Ischemic heart disease requiring drug therapy
    • Peripheral arterial disease and/or cerebrovascular disease and/or vascular
    surgery.
    • History of stroke or myocardial infarction
    • Congestive heart failure NYHA Class II-IV
    • History of pancreatitis or peptic ulcers
    • Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
    • Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL)
    • ALT or AST ≥ 5 times the ULN

    • Within 3 months prior or during the study
    o Intraarticular injections of hyaluronic acid products in the index knee
    o Arthroscopy of the index knee
    o Tricyclics
    • Within 2 months prior or during the study
    o Oral, inhaled or parenteral corticosteroids (depot steroids 6 months)
    o Change in oral treatment regimen of glucosamine, chondroitin sulfate,
    shark cartilage, methylensulfonylmethan (MSM), Vitamin E, diacerin or
    nutraceuticals
    • Within 1 month prior or during the study
    o Intraarticular injections of corticosteroids in the index knee within 1
    months prior to screening or during the study
    o Antiepileptic drugs
    o Acupuncture or physical therapy of the index knee including ice/heat packs
    and massage
    • Unable to discontinue therapy with proton-pump inhibitors, H2 inhibitors
    and analgesic therapy including opioids, NSAID´s, tramadol, muscle
    relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or
    any other drug approved or used for the treatment of pain for the
    duration of the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is:
    • Change from baseline at Week 12 on the entire pain subscale of the
    WOMAC (NRS)
    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 Yes
    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.8.3 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 concerned35
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA80
    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
    The end of study is defined by closure of database for CL-033-III-03.
    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 months4
    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 months4
    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 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 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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1320
    F.4.2.2In the whole clinical trial 1320
    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)
    normal treatment of the indication
    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 Decision2008-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-11
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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