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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   38942   clinical trials with a EudraCT protocol, of which   6397   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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    EudraCT Number:2004-004776-37
    Sponsor's Protocol Code Number:VOSG-PE-314
    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:2005-02-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2004-004776-37
    A.3Full title of the trial
    An 8-week, multi-center, randomized, double-blind, placebo-controlled, parallel group trial of Diclofenac Sodium Gel 1% in patients with primary osteoarthritis of the hand
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberVOSG-PE-314
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 S.A.
    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.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 Information not present in EudraCT
    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 10 mg/g (1%) Gel
    D.3.2Product code GP-45840
    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 INNDiclofenac sodium
    D.3.9.1CAS number 15307-79-6
    D.3.9.2Current sponsor codeGP-45840
    D.3.9.3Other descriptive nameNSAID
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary osteoarthritis of the hand.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10058192
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of DSG 1%, applied four times a day vs. placebo in OA of the hand, based on assessment of three efficacy outcomes, each assessed on a 100 mm VAS, at Week 4 and Week 6:

    - OA pain intensity in the dominant (target) hand over the last 24 hours.

    - Total AUSCAN (Australian/Canadian) Osteoarthritis Hand Index score for the dominant hand.

    - Patient global rating of disease activity.
    E.2.2Secondary objectives of the trial
    1. Onset of efficacy of DSG in the dominant hand by assessment of above efficacy outcomes at the study site during the visits at Weeks 1 and 2, and by assessment of daily OA pain intensity in the diary over Days 1-14.

    2. Durability of efficacy of DSG in the dominant hand by assessment of above efficacy outcomes at the study site during the visits at Week 8.

    3. Effect of DSG in the non-dominant hand by assessment of OA pain intensity as well as the pain and function subscales of the AUSCAN index at the study site during all visits.

    4. Safety and tolerability profile of DSG vs. placebo over 8 weeks.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    At Screening:

    The patient must:

    1. Understand the procedures, agree to participate, and give written informed consent prior to initiation of any study procedure.
    2. Be able to indicate right- or left-handedness. The dominant hand will be the target hand for the primary efficacy analysis. Both right and left-handed subjects are included.
    3. Have a diagnosis of primary hand OA according to ACR criteria with symptoms including pain for at least 12 months (see Post-text supplement 1),
    - with a least two painful episodes in at least one finger joint during this period,
    - reporting use of a NSAID or salicylate whether oral or topical, during at least one of these episodes, and
    - reporting pain on > 15 days during the preceding 30 day period.
    4. Report that pain is usually greater in the dominant hand.
    5. Expect to need to treat the target hand for at least 7 weeks.
    6. Be ≥ 40 years of age.
    7. Females must be
    - surgically sterilized (tubal ligation or hysterectomy), or post-menopausal for at least 12 months past last natural menses or FSH ≥20 IU/L and serum estradiol ≤18 pg/mL, or
    - practicing an acceptable form of birth control for greater than 2 months prior to screening visit (defined as the use of an IUD, a barrier method with spermicide, condoms, subdermal implants or oral contraceptives). Females of child bearing potential must continue to practice their birth control during the trial.
    8. Be fluent in the language in which each questionnaire is presented at the site.
    9. Be able to comply with the assessment requirements, and to report AEs, intake of rescue medication and concomitant medication for the duration of the study.

    At Baseline:

    The patient must:

    1. Rate pain in the target hand during previous 24 hours ≥ 40 mm on a 100 mm VAS.
    2. If washed out from NSAIDs between screening and baseline visit, show an increase of pain over the past 24 hours in the target hand of ≥ 15 mm (on a 100 mm VAS) between the screening and the baseline visit.
    3. If there is pain in the non-dominant hand, the rating of pain over the past 24 hours must be at least 20 mm lower (on a 100 mm VAS) than the corresponding rating in the target hand.
    4. Have a posterior-anterior X-ray of the dominant hand, no more than one year old, showing signs of OA in the same painful joints with Kellgren-Lawrence grade 1, 2, or 3 disease in the dominant hand (Kellgren and Lawrence 1957). The specific use of the Kellgren-Lawrence grading for hand OA is detailed in Post-text supplement 2 (Hart and Spector 2000).
    5. Females of childbearing potential must have a negative pregnancy test.
    6. Confirm willingness to avoid the use of other topical or systemic (Rx or OTC) analgesic or anti-inflammatory treatments other than the study medications during the course of the study, including other topical anti-arthritic medications such as capsaicin or salicylate.
    E.4Principal exclusion criteria
    1. Secondary post-traumatic OA, history and/or evidence of any other rheumatic disease involving the potential target hand or the arm: algodystrophy, septic arthritis, inflammatory joint disease (e.g. psoriatic arthritis), rapidly destructive osteoarthropathy, chondrocalcinosis, gout, recurrent episodes of pseudogout, Paget’s disease of bone, articular fracture, ochronosis, acromegaly, hemochromatosis, primary osteochondromatosis, heritable disorders , collagen gene mutations, carpal tunnel syndrome, Dupuytren’s disease and neurological diseases of the hand or arm.
    2. Symptomatic OA at additional locations besides the hand(s), requiring any symptomatic or disease-modifying treatment at present or patient anticipates to require such treatment.
    3. Radiological signs of OA Kellgren-Lawrence grade 4 disease in the dominant hand.
    4. Adult juvenile chronic arthritis.
    5. History of rheumatoid arthritis or laboratory values indicative of rheumatoid arthritis with subsequent diagnosis by a physician.
    6. History of other inflammatory diseases such as colitis within the previous year.
    7. History of fibromyalgia within the previous year.
    8. Laboratory values with clinically significant abnormalities. Patients with elevated ESR or CRP are excluded only if clinical signs indicate an underlying clinically significant disease and in particular if both parameters are elevated.
    9. Females who are pregnant or lactating.
    10. Evidence of active peptic ulceration within the previous 12 months or history of GI bleeds.
    11. Evidence of liver disease and/or evidence of alcohol or drug abuse.
    12. Known hypersensitivity to analgesics, antipyretics, NSAIDs or any ingredients in the study medication, e.g. isopropyl alcohol or propylene glycol.
    13. Not able to tolerate rescue medication with paracetamol.
    14. Skin lesions or wounds in the area to be treated with the study medication on either the dominant or the non-dominant hand.
    15. History of malignancy of any organ system, treated or untreated, within the past five years whether or not evidence of local recurrence or metastases exists, with the exception of localized basal cell carcinoma of the skin.

    16. Significant medical problems, including but not limited to the following: uncontrolled hypertension, heart failure, type I diabetes (well controlled type II diabetes is allowed even when requiring insulin), thyroid disease (unless the patient is controlled for at least 3 months, with or without thyroid hormone substitution), known HIV seropositivity.
    17. History of noncompliance to medical regimens or considered unreliable.
    18. Use of medications prohibited before or during the study.
    19. Use of any of the physical therapies listed among Concomitant therapies that are not allowed during the study.
    20. Expects to introduce, discontinue, or change physical therapy during the study, or initiate a new exercise regime or increase the rigor of the current exercise regime. Current physical therapy must have been started at least 3 months before screening.
    21. Failure to indicate a dominant hand, i.e. truly ambidextrous. Must indicate same hand used preferentially for all activities described in Questions 10-14 of the AUSCAN physical function index.
    22. Inability to apply the gel correctly to either hand.
    E.5 End points
    E.5.1Primary end point(s)
    At 4 and 6 weeks of treatment (DSG 1% vs. placebo, all based on evaluations on a 100 mm VAS):

    1. OA pain intensity in the target hand (in the previous 24 hours).

    2. Global rating of disease activity.

    3. Total AUSCAN score in the target hand (unweighted sum of the scores on 15 questions).
    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 No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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. 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) No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    Enrollment will stop when the overall target number of patients is reached. The planned termination for this trial will be week 8 for all 360 patients (180 per group). On completion of the study, the 'Final Visit' page of the CRF will be completed.

    Premature termination of the study must be mutually agreed upon by the Lead Investigator and Novartis and must be documented. However, study results will be reported according to the requirements outlined in the protocol as far as it is applicable.
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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 Information not present in EudraCT
    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 2005-02-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 360
    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, health-care provider and standard treatment.
    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 Decision2005-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
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